Clinical Trial Database
| S/N | Title of Study | Study Acronyms | Phase of Study | Name of Applicant | Principal investigator | Address of Applicant | Application Date | Name of Sponsor | Sponsor Details | Trial Site(s) | Product Type | Status of Clinical Trial Application | Trial Authorisation Date | Status of Approved Trial(s) | GCP Inspection | Type of inspection | Regulatory action/ Compliance |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial) | The STEP-Mag Trial) | Prof. Hadiza Shehu Galadanci | Prof. Hadiza Shehu Galadanci | Africa Center of Excellence for Population Health and Policy, College of Health Sciences, Aminu Kano Teaching Hospital [AKTH, Off Zaria Rd, Unguwa Uku, Kano | Feb-19-2026 | WHO Department of Sexual and Reproductive Health and Research World Health Organization Avenue Appia 20 1211 Geneva 27 Switzerland | 1. Murtala Muhammad Specialist Hospital. 2. Aminu Kano Teaching Hospital. 3.Muhammad Abdullahi Wase Teaching Hospital, Kano State. 4.Usman Danfodio University Teaching Hospital, Sokoto | Drug(Magnesium sulfate) | Approved | 27th March 2026 | Ongoing | Scheduled | Routine Monitoring Inspection | NA | ||
| 2 | Impact of azithromycin prophylaxis on antimicrobial resistance in adults with advanced HIV disease - A REVIVE sub study | REVIVE AMR | 3 | Dr. Olukemi Adekanmbi | Dr. Olukemi Adekanmbi | Department of Medicine University College Hospital Queen Elizabeth Road, Mokola, Ibadan | Feb-20-2026 | Population Health Research Institute, Hamilton, Ontario, Canada | 1. University College Hospital, Ibadan 2. Jos University Teaching Hospital, Jos 3.Usmanu Danfodiyo University Teaching Hospital, Sokoto 4.Lagos University Teaching Hospital 5. University of Calabar Teaching Hospital, Calabar 6. Aminu Kano Teaching Hospital | Drug(Azithromycin) | Screening Unsatisfactory.Compliance Directive sent | NA | NA | NA | NA | NA | |
| 3 | Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial) | The STEP-Mag Trial) | 3 | Prof. Hadiza Shehu Galadanci | Prof. Hadiza Shehu Galadanci | Africa Center of Excellence for Population Health and Policy, College of Health Sciences, Aminu Kano Teaching Hospital [AKTH, Off Zaria Rd, Unguwa Uku, Kano | Feb-19-2026 | WHO Department of Sexual and Reproductive Health and Research World Health Organization Avenue Appia 20 1211 Geneva 27 Switzerland | 1. Murtala Muhammad Specialist Hospital. 2. Aminu Kano Teaching Hospital. 3.Muhammad Abdullahi Wase Teaching Hospital, Kano State. 4.Usman Danfodio University Teaching Hospital, Sokoto | Drug(Magnesium sulfate) | Approved | 27th March 2026 | Ongoing | Yet to be Conducted | Routine Monitoring Inspection | NA | |
| 4 | Impact of azithromycin prophylaxis on antimicrobial resistance in adults with advanced HIV disease - A REVIVE sub study | REVIVE AMR | 3 | Dr. Olukemi Adekanmbi | Dr. Olukemi Adekanmbi | Department of Medicine University College Hospital Queen Elizabeth Road, Mokola, Ibadan | Feb-20-2026 | Population Health Research Institute, Hamilton, Ontario, Canada | 1. University College Hospital, Ibadan 2. Jos University Teaching Hospital, Jos 3.Usmanu Danfodiyo University Teaching Hospital, Sokoto 4.Lagos University Teaching Hospital 5. University of Calabar Teaching Hospital, Calabar 6. Aminu Kano Teaching Hospital | Drug(Azithromycin) | Screening Unsatisfactory.Compliance Directive sent | NA | NA | NA | NA | NA | |
| 5 | A Phase Ii, Multicenter, Randomized, Double-Blind Study Of Tobemstomig/Ro7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nabpaclitaxel In Participants With Previously Untreated, Pd-L1Positive, Locally-Advanced Unresectable Or Metastatic Triple-Negative Breast Cancer | 2 | Terver Akindigh | Roche Lagos | 08/01/2024 | F. Hoffmann-La Roche Ltd. | Roche Global | Marcelle Ruth Cancer Center and Specialist Hospital, Victoria Island Lagos | Tobemstomig/Ro7247669 Combined With Nab-Paclitaxel | Approved | Ongoing | NA | NA | NA | |||
| 6 | Efficacy, tolerability and safety of new or repurposed drugs against Lassa fever in West Africa | LASSA FEVER | 2 and 3 | Pr. Sylvanus OKOGBENIN | Pr. Sylvanus OKOGBENIN | Irrua Specialist Teaching Hospital (ISTH), Irrua | 2/2/2024 | Irrua Specialist Teaching Hospital (ISTH), Irrua | Irrua Specialist Teaching Hospital 2. Federal Medical Centre, Michael Adekunle Ajasin Road ,Lagos State University Teaching Hospital 3. Aminu Kano Teaching Hospital, Lagos 4. Federal Medical Centre, Abuja 5. University of Port Harcourt Tecahing Hospital 6. University of Abuja Tecahing Hospital,Gwalgwalada, Abuja. University College Hospital, Ibadan 8. Irrua Specialist Teaching Hospital, Edo State | Approved | Ongoing | GCP Inspection Conducted | Routine Monitoring Inspection | Notice of Inspection findings sent to PI | |||
| 7 | SMART (Smallpox vaccine for Monkeypox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial | SMART | 2 | Prof Dimie Ogoina | Prof Dimie Ogoina | Niger Delta University Teaching Hospital, Okolobiri, Bayelsa | 02/01/2024 | McMaster University , Canada | Niger Delta University Teaching Hospital, Okolobiri, Bayelsa 2. | Smallpox vaccine | Approved | Completed | NA | NA | NA | ||
| 8 | CLARITHROMYCIN VERSUS LEVOFLOXACIN-BASED TRIPLE THERAPY AS THE FIRST LINE FOR THE ERADICATION OF HELICOBACTER PYLORI | 2 | Dr. Igbiti Justice | Dr. Igbiti Justice | University of Abuja Teaching Hospital, Abuja | 27/02/2024 | Dr. Igbiti Justice | University of Abuja Teaching Hospital, Abuja | University of Abuja Teaching Hospital, Abuja | Approved | Ongoing | NA | NA | NA | |||
| 9 | TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy | Dr Atara Ntekim | Dr Atara Ntekim | University College Hospital, Ibadan, Nigeria | 17/03/2024 | University of Chicago Center for Global Health (UC CGH) | University College Hospital, Ibadan, Nigeria | University College Hospital, Ibadan, Nigeria | Approved | Ongoing | Inspection Conducted | Routine Monitoring Inspection | Notice of Inspection findings sent to PI | ||||
| 10 | Assessing the efficacy and safety of optimal neoadjuvant to adjuvant anti-HER2- based therapy in Nigerian women with HER2+ Breast Cancer (ARETTA II). | ARETTA II | 2 | Dr Atara Ntekim | Dr Atara Ntekim | University College Hospital, Ibadan, Nigeria | 09/01/2024 | University of Chicago Center for Global Health (UC CGH) | University of Chicago Center for Global Health (UC CGH) | University College Hospital, Ibadan, Nigeria | neoadjuvant | Approved | Ongoing | Inspection Conducted | Routine Monitoring Inspection | Notice of Inspection findings sent to PI | |
| 11 | A global phase 3, randomised, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat in adolescents and adults with sickle cell disease | A research study to evaluate how well etavopivat works in people with sickle cell disease - Hibiscus 2 CTA 467 | Phase 3 | Aster Pearce | Okpala, Iheanyi | LAgos Executive Business Lounge, Office 12, 54b Adeniyi Jones Ave, Oba Akran, Ikeja, Lagos, Nigeria. | 14-Nov-24 | Novo Nordisk A/S | Novo Allé, 2880 Bagsvaerd, Denmark | 1. Hematology Department, University of Nigeria Teaching Hospital, Enugu, Nigeria 2. Department of Haematology, College of Health Sciences, University of Abuja 3. Department of Paediatrics College of Medicine 4. College of Medicine, University of Lagos | Drug | Approved | NA | NA | NA | NA | NA |
| 12 | Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial | REACH CTA 392 | Phase 3 | Aster Pearce | Prof. Oladapo OLAYEMI | LAgos Executive Business Lounge, Office 12, 54b Adeniyi Jones Ave, Oba Akran, Ikeja, Lagos, Nigeria. | 02-Oct-24 | WHO | WHO Headquarters Avenue Appia 201211, Geneva, Switzerland | 1. Department of Obstetrics and Gynaecology, State Specialist Hospital, Oke-Aro Akure (formerly Mother and Child Hospital, Oke-Aro Akure), Ondo State, Nigeria 2. Department of Obstetrics and Gynaecology University of Abuja Teaching Hospital Gwagwalada, Abuja, Nigeria 3. Department of Obstetrics and Gynaecology, College of Medicine, University of Lagos/Lagos University Teaching Hospital, Lagos, Nigeria | Drug | Under review | NA | NA | NA | NA | NA |
| 13 | Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry | Niraparib CTA 370 | Phase 4 | Hamidu Ahmad Umdagas | Hamidu Ahmad Umdagas | Department of Obstetrics and Gynecology University of Miami Sylvester Comprehensive Cancer Center 1475 NW 12th Ave Miami, FL 33136 | 22-Jun-24 | University of Miami Office of the Vice Provost for Research and Scholarship (UM OVPRS) Sylvester Comprehensive Cancer Center 1475 NW 12th Ave Miami, FL 33136 | Protocol Development Office Sylvester Comprehensive Cancer Center University of Miami | 1. Ahmadu Bello University Teaching Shika-Zaria | Drug | Approved | Ongoing | Yet to be Conducted | NA | NA | |
| 14 | Azithromycin use in labour to prevent maternal sepsis among pregnant women undergoing vaginal birth in Nigeria (AZIN-V): a cluster-randomised hybrid type-2 effectiveness implementation trial. | AZIN-V (CTA 390) | Phase 3 | Prof. Bosede Bukola Afolabi | Prof. Bosede Bukola Afolabi | College of Medicine University of Lagos | 14-Aug-24 | College of Medicine University of Lagos | College of Medicine, University of Lagos Ishaga road, Idi-Araba, Mushin, Lagos | 1.National Obstetrics Fistula Centre, Abakaliki 2.Sabo Bakin Zuwo General Hospital 3. Sheik Jeddah General Hospital 4. Chima Hospital and Maternity 5. Mater Hospital, Afikpo 48. And other sites across the country | Drug | Approved | Ongoing | Conducted (4 sites) | Routine Monitoring Inspection | Notice of Inspection findings sent to PI | |
| 15 | Feasibility of a Clinic-based Intervention of Biofeedback and Health Education Coupled with a Digital Home Program for Nigerian Women with Pelvic Floor Disorder Symptoms | Technology-guided PFMT for Nigerian Women(CTA 384) | Phase 4 | Dr. Laura Keyser | Dr. Babafemi Daniyan | 2120 Commonwealth Avenue, Suite 1 Auburndale, MA 02466 USA | 23-Jul-24 | Axena Health, Inc. | 2120 Commonwealth Avenue, Suite 1 Auburndale, MA 02466 USA | 1. University of Abuja Teaching Hospital 2. Lagos State University Teaching Hospital | Medical Device | Approved | Ongoing | Yet to be Conducted | NA | NA | |
| 16 | Phase 1 Open-Label, Multiple-Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of FTX-6058 in Subjects with Sickle Cell Disease (SCD) | PIONEER(CTA 391) | Phase 1 | Ishola Olatayo(MCT) | Dr. Blessing Onyinye Ojika | MCT-CRO, Lagos, Nigeria | 15-Jul-24 | Fulcrum Therapeutics, Inc. | 26 Landsdowne Street Cambridge, MA 02139 USA | 1. National Hospital Abuja | Drug | Approved | Ongoing | Yet to be Conducted | NA | NA | |
| 17 | Stroke Minimization through Additive Anti-atherosclerotic agents in Routine Treatment II (SMAART-II): A Phase 3 Randomized Clinical Trial | SMAART-II(CTA-398) | Phase III | Prof. Kolawole Wahab | Prof. Kolawole Wahab | Neurology Unit, Department of Medicine, University of Ilorin Teaching Hospital, Ilorin, Kwara State, Nigeria | 21-Sep-24 | Northern California Institute of Research and Education | Neurology Unit Department of Medicine University of Ilorin Teaching Hospital Ilorin, Nigeria | 1. University of Ilorin Teaching Hospital 2. Lagos University Teaching Hospital 3. Ahmadu Bello University Teaching Hospital 4. Benue State University Teaching Hospital 5. General Hospital, Sabon Gari 6. General Hospital, Ilorin | Drug | Approved | Ongoing | Yet to be Conducted | NA | NA | |
| 18 | A Phase III/IV factorial randomised double-blind trial to compare the addition of dapagliflozin versus placebo, and rosuvastatin/ezetimibe versus pitavastatin, in patients with HIV on integrase strand transfer inhibitor-based antiretroviral therapy with elevated metabolic risk (the OPTIMAR study). | OPTIMAR | Phase 3/4 | Nnakelu Eriobu | Nnakelu Eriobu | Institute of Human Virology Nigeria | 28-Aug-24 | University of New South Wales, The Kirby Institute, University of New South Wales, Australia 2052 | Kirby Institute Level 6, Wallace Wurth Building University of New South Wales Sydney 2052, Australia | 1. University of Abuja Teaching Hospital Gwagwalada | Drug | Under review | NA | NA | NA | NA | NA |
| 19 | A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF TOBEMSTOMIG/RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NABPACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER | CTA 305 | Phase 2 | Roche Products Limited Nigeria,Terver Akindigh | Dr Atara Ntekim | 2ND FLOOR, 48/50 ISAAC JOHN STREET, IKEJA GRA, LAGOS, NIGERIA | 08-Jan-24 | F. Hoffmann-La Roche Ltd | 2ND FLOOR, 48/50 ISAAC JOHN STREET, IKEJA GRA, LAGOS, NIGERIA | 1. University College Hospital Ibadan 2. Marcelle Ruth Cancer Center and Specialist Hospital | Drug | Yet to be Conducted | NA | NA | |||
| 20 | A Randomized, Single-Blinded Phase III Bridging Trial Comparing the Efficacy and Safety of Two Elsulfavirine (Elpida)-based ARTs with Fixed Dose Combination Tenofovir/Lmivudine/Dolutogravir (TLD) among ART-naive HIV-infected Adults accessing care in Nigeria [CEEDAR-Phase III Bridging Trial] | CEEDAR-Phase III Bridging Trial(CTA-0000000453) | Phase 3 | Prof. Ibrahim Musa Kida | Prof. Ibrahim Musa Kida | Department of Infectious Disease and Clinical Immunology, University of Maiduguri | 26-Jan-25 | OAKE Legal | 1 Zambezi Crescent, Maitama, Abuja, Nigeria | 1. University of Maiduguri Teaching Hospital | Drug | NA | NA | NA | NA | NA | |
| 21 | A phase III, Multicenter, Randomized, Placebo Controlled, Double blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) versus placebo, with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Frequent Vaso-Occlusive Crises | SPARKLE(CTA 442) | Phase 3 | Nguavese Saror | Prof. Obiageli Nnodu | Novartis Nigeria Limited Regulatory Affairs, GDD Pharma Division Landmark House – 3rd Floor Plot 52-54 Isaac John Street, Ikeja GRA Lagos Nigeria | 28-Feb-25 | Novartis Pharma AG | Novartis Pharma AG Lichtstrasse 35 CH-4056, Basel Switzerland | 1. University of Abuja, Centre of Excellence for Sickle Cell Disease Research and Training, University of Abuja, FCT Abuja. 2. Department of Haematology, AEFUTHA. No 1 Chidume street Abakaliki Ebonyi State, NIGERIA 3. .Haematology Department,University of Nigeria Teaching hospital,Eugu 4.Department of Paediatics, University College Hospital Ibadan. Oyo State, Nigeria 5. Lagos University Teaching Hospital, Idi-Araba, Lagos - Nigeria. | Drug | Under review | NA | NA | NA | NA | NA |
| 22 | PD-1 (Programmed cell death protein 1) blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria | PD-1 CTA 493 | Phase 2 | Prof. Olusegun Alatise | Prof. Olusegun Alatise | Obafemi Awolowo University Teaching Hospital Complex | 17-Jun-25 | Memorial Sloan Kettering Cancer Center | 1275 York Avenue New York, NY 10065 | 1.Obafemi Awolowo University Teaching Hospital Complex 2. Lagos University Teaching Hospital | Drug | Under review | NA | NA | NA | NA | NA |
| 23 | An open-label, randomised, controlled, non-inferiority trial to compare the efficacy, safety and tolerability of a fixed-dose Triple Artemisinin-based Combination Therapy (TACT) artemether-lumefantrine-amodiaquine versus first-line Artemisinin-based Combination Therapies (ACTs) for the treatment of uncomplicated Plasmodium falciparum malaria | CTA 525 | Phase 3 | Olugbenga Ayodeji MOKUOLU | Olugbenga Ayodeji MOKUOLU | Centre for Malaria and Other Tropical Diseases Care, University of Ilorin Teaching Hospital | 14-Jul-25 | University of Oxford Research Governance, Ethics and Assurance, Boundary Brook House, Churchill Drive, Oxford OX3 7GB United Kingdom | Boundary Brook House, Churchill Drive, Oxford OX3 7GB United Kingdom | 1. Ajikobi Cottage Hospital Okekare Omodada Street Ilorin, Kwara State, Nigeria | Drug | Under review | NA | NA | NA | NA | NA |
| 24 | Cervical Cancer and Tampon-Based HPV Screening in Nigeria (CATCH Study) | CATCH STUDY CTA479 | Phase 3 | Dr. Timothy Akinmurele | Professor Oluwarotimi Ireti Akinola | 2b Itohan Avenue, Off Obafemi Awolowo Way, Ikeja | 09-Jul-25 | Grand Challenges Canada | MaRS Centre, South Tower, at 101 College Street, Suite 406, Toronto, Canada. | 1. Lagos State University Teaching Hospital 2. Federal Medical Centre | Daye Diagnostic tampon | Under review | NA | NA | NA | NA | NA |
| 25 | Multicentre non-inferiority cluster randomised trial testing Disposable versus Reusable drapes and Gowns for green OperatiNg theatres | DRAGON Ttrial CTA 450 | Pilot Phase | Prof Adesoji Ademuyiwa | Emmanuel Williams | Room 307, College of Medicine University of Lagos, Idi-Araba, Lagos Nigeria. | 03-Feb-25 | The University of Birmingham | Research Strategy & Services Division – Research Ethics, Governance and Integrity University of Birmingham Birmingham, B15 2TT researchgovernance@contacts.bham.ac.uk | 1. Lagos University Teaching Hospital 2. Obafemi Awolowo University Teaching Hospital Complex 3. University of Ilorin Teaching Hospital 4. Lagos State University Teaching Hospital | Medical Device | Under review | NA | NA | NA | NA | NA |
| 26 | A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Gallium Maltolate in Adult Black African Patients with Relapsed or Treatment-Refractory Glioblastoma Multiforme (GBM) | GaM-GBM Black African Phase-1 Study CTA 515 | Phase 1 | Samir Udani | Dr. Adeniji. A. Adeoluwa | Apapa Oshodi Expressway, Oshodi. Lagos. Nigeria | 05-Jun-25 | Stillpoint Ltd. | Apapa Oshodi Expressway, Oshodi. Lagos. Nigeria | 1. MeCure Cancer Center | Drug | Under review | NA | NA | NA | NA | NA |
| 27 | Randomized Controlled Trial of Surfactant Administered via Supraglottic Airway Device (SALSA) Compared to Endotracheal Tube (InSurE) on Survival without Mechanical Ventilation in Preterm Neonates with Respiratory Distress Syndrome in Sub-Saharan Africa | SALSA trial(CTA 488) | Phase 3 | Ayodeji Akinola | Elizabeth Aruma Disu | LAGOS STATE UNIVERSITY TEACHING HOSPITAL | 02-Jun-25 | Vermont Oxford Network | Vermont Oxford Network 33 Kilburn Street Burlington, Vermont 05401 Phone:+18028654814 | 1. LAGOS STATE UNIVERSITY TEACHING HOSPITAL | Medical Device | Approved | 12/11/2025 | Approved | Yet to be Inspected | NA | NA |
| 28 | A Phase 2, single-center, open-label, randomized, dose ascending trial to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery | EX005-201 CTA-0000000547 | Phase 2 | Prof. Hadiza Shehu Galadanci | Prof. Hadiza Shehu Galadanci | P.M.B. 700233, AKTH Campus Kano – Nigeria | 25-Jul-25 | Chemo Research S.L | Chemo Research. Manuel Pombo Angulo, 28 3ª planta 28050 Madrid – España | 1. Aminu Kano Teaching Hospital, Kano | Drug | Under review | NA | NA | Yet to be Inspected | NA | NA |
| 29 | Differences in Immunological effects of Vitamin D Replacement Among Native West African (WA) Prostate Cancer Patients with Localized Versus Metastatic Diseases | Impact of Vitamin D supplementation in advanced prostate cancer | Phase 3 | Olubunmi Dada | Professor Ademola Alaba Popoola | University of Ilorin Teaching Hospital, Ilorin Nigeria | 05-Mar-25 | Mayo Clinic Jacksonsville | Mayo Clinic Comprehensive Cancer Center |214 Hogan N. St | Jacksonville, FL 32202 | q. University of Ilorin Teaching Hospital, Ilorin Nigeria | Drug | Approved | NA | Under Review | Yet to be Conducted | NA | NA |
| 30 | Vitamin D₃ for Mild-to-Moderate Traumatic Brain Injury (VIMOT Trial) | VIMOT Trial (CTA 567) | Phase 2 | Olufemi Idowu | Prof Olufemi Idowu | Department of Surgery, Lagos State University Teaching Hospital Ikeja | 13-Nov-25 | Lagos State University Teaching Hospital | 1-5 OBA AKINJOBI ROAD | Department of Surgery, Lagos State University Teaching Hospital Ikeja | Drug | Approved | 21/01/2026 | Approved | Yet to be Conducted | NA | NA |
| 31 | The effects of tranexamic acid on anaemia, menstrual health and the wellbeing of women: an international randomised, placebo-controlled trial among menstruating women with anaemia | Tranexamic for anaemia trial WOMAN-3 (CTA 574) | Phase 3 | Professor Folasade Adenike Bello | Professor Folasade Adenike Bello | WOMAN-3 Trial Coordinating Centre, University College Hospital, Queen Elizabeth Road, Ibadan, Nigeria | Dec-03-2025 | London School of Hygiene & Tropical Medicine (LSHTM) | LSHTM Clinical Trials Unit, Keppel Street, London, WC1E 7HT, United Kingdom | Queen Elizabeth II Road, Ibadan, Oyo State | Drug | Review in Progress | NA | NA | Yet to be Conducted | NA | NA |
| 32 | Traxenamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placembo controlled trial | The CRASH-3 trial | Phase 3; | Prof. Bukola Fawole | Dr Temitayo Shokumbi | University College Hospital, Ibadan | 19/03/2013 | London School of Hygiene & Tropical Medicine | Clinical Trial Unit, London School of Hygiene & Tropical Medicine, Room 180, Keppel Street, London WC1E 7HT, UK | 1. Lagos University Teaching Hospital 2. National Hospital Abuja 3. Obafemi Awolowo University Teaching Hospital, Osun 4. University College Hospital, Ibadan 5. Abubakar Tafawa Balewa University Teaching Hospital 6. Olabisi Onabanjo University Teaching Hospital, Ogun 7. Irrua Specialist Hospital, Oyo State 8. Federal Medical Centre, Bida 9. Federal Medical Centre, Abeokuta 10. Federal Medical Centre, Umuahia 11. Bowen University Teaching Hospital 12. Federal Medical Centre, Lokoja | Drug | Approved | 19/03/2013 | Completed | Inspection not Conducted | NA | NA |
| 33 | Safety and immunogenicity study of GSK Biologicals' investigational recombinant chimpanzeeb adenovirus Type 3-vectored Ebola Zaire vaccine (GSK3390107A) in adults in Africa. EBOLA Z CHAD3-005-202091 | CHIMPANZEE Trial | Phase 2; | Quintiles Clindepharm (Pty) Limited | Prof S. Oguche | 1011 Pretorius Avenue South Lyettelton Manor, 0157 P.O Box 868 Irene , 0062 Republic of South Africa. | 12/01/2015 | GlaxoSmithKline Biologicals SA | Rue de I'Institut, 89 B-133O Rixensart, Belgium | 1. Jos University Teaching Hospital / APIN 2. Walter Reed Program Nigeria Clinical Research Center | Vaccine | Approved | 19/06/2015 | Completed | Inspection not Conducted | NA | NA |
| 34 | A phase III, randomised, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally | WHO Carbetocin RTS Study | Phase 3; | Dr Bukola Fawole | Dr Bukola .Fawole | Department of Obsterics & Gynaecology , University College Hospital, Ibadan | 03/02/2015 | Department of Reproductive Health & Research, World Health Organization | Avenue Appia 20 1211 Geneva 27 switzerland | 1. Department of Obstetrics & Gynaecology, University College Hospital, Ibadan. | Drug | Approved | 21/04/2015 | Completed | Inspection not Conducted | NA | NA |
| 35 | A phase III, randomized, double blind, active, controlled, multi national, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of post partum haemorrhage during the third stage of labour in women delivering vaginally | CHAMPION Trial | Phase 3; | Prof Bukola Fawole | Prof Bukola Fawole | Department of Obstetrics & Gynaecology, College of Medicine, University of Ibadan | 03/02/2015 | Department of Reproductive Heath & Research, World Health Organization | Avenue Appia 20 1211 Geneva 27 Switzerland | 1. University College Hospital, Ibadan 2. Mother and Child Hospital, Akure | Drug | Approved | 29/06/2015 | Completed | Scheduled but not conducted | NA | NA |
| 36 | A Comparative study of the block characteristics of Spinal Bupivacaine alone and spinal Bupivacaine with Dexmedetomidine for lower abdominal surgeries | Pilot Study | Dr Uwandu Chigozie Benedeth | Dr Uwandu Chigozie Benedeth | Department of Anasthesia, University of Port Harcourt Teaching Hospital | 02/04/2015 | Dr Uwandu Chigozie Benedeth | Department of Anasthesia, University of Port Harcourt Teaching Hospital | Department of Anaesthesia, University of Port Harcourt Teaching Hospital | Drug | Approved | 24/06/2015 | Completed | Inspection not Conducted | NA | NA | |
| 37 | A randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events | IVVE | Phase 3; | Prof Kamilu M. Karaye | Prof Kamilu M. Karaye | Department of Medicine, Aminu Kano Teaching Hospital, Kano, Nigeria | 26/11/2015 | McMaster University | 1280 Main St W, Hamilton, ON, L8S 4L8, Ontario, Canada | 1. Murtala Muhammed Specialist Hospital, Kano 2. Aminu Kano Teaching Hospital, Kano 3. University College Hospital, Ibadan 4. Obafemi Awolowo University Teaching Hospital, Ile Ife | Vaccine | Approved | 30/08/2016 | Ongoing | Inspection Conducted | Routine | Notice of Findings sent out to PI |
| 38 | A randomised, observer-blind, placebo-controlled, two part, phase 2 study to evaluate the safety, tolerability and immunogencity of two prime-boost regimens of the candidate prophylactic vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo;VAC52150EBL2003 | Ebola study (Jand J) | Phase 2; | U.S Department of Defense Walter Reed Program-Nigeria | 7, Usuma Street, Maitama, Abuja, Nigeria | 14/04/2016 | Janssen Vaccines & Prevention B.V. | Archimedesweg 4-6 2333 CN Leiden The Netherlands | Clinical Research Center ,7, Usuma Street, Maitama, Abuja, Nigeria | Vaccine | Approved | 30/08/2016 | Completed | Inspection not Conducted | NA | NA | |
| 39 | Primary Prevention of Stroke in Nigerian Children with Sickle Cell Disease in Sub Saharan Africa II: a partial double blind randomized Phase III clinical trial | SPRING TRIAL | Phase 3; | Aminu Kano Teaching Hospital | Zaria road, Kano | 20/09/2016 | Vanderbilt University School of Medicine | Nashville USA | 1. Aminu Kano Teaching Hospital, Kano 2. Murtala Mohammed Specialist Hospital, Kano 3. Barau Dikko Teaching Hospital, Kaduna | Drug | Approved | 09/02/2017 | On going | Conducted on 29 th and 30th April, 2025 | Routine | Notice of Findings sent out to PI | |
| 40 | Cardiovascular Changes in sickle cell crises and impact of arginine supplementation in vaso-occlussive crisis and acute chest syndrome | Argenine supplementation | Phase 3; | Dr. Richard Onalo | Dr. Richard Onalo | Department of Paediatrics, University of Abuja Teaching Hospital, Gwagwalada, Abuja | 22/02/2017 | Dr. Richard Onalo & Tertiry Education Trust Fund | Department of Paediatrics, University of Abuja Teaching Hospital, Gwagwalada, Abuja | Department of Paediatrics, University of Abuja Teaching Hospital, Gwagwalada, Abuja | Drug | Approved | 13/11/2017 | Completed | Inspection Conducted | Routine | Notice of findings sent out to PI. |
| 41 | CREOLE Study: Comparison of Three Combination Therapies in Lowering Blood Pressure in Black African | CREOLE Study | Phase 4 | Dr. Dike Ojji | Dr. Dike Ojji | Cardiovascular Disease Research Office, NHIS/Family Medicine Complex, University of Abuja Teaching Hospital, Gwagwalada, Abuja | 29/03/2017 | University of Abuja | Cardiovascular Disease Research Office, NHIS/Family Medicine Complex, University of Abuja Teaching Hospital, Gwagwalada, Abuja | 1. Aminu Kano Teaching Hospital, Kano 2. University of Abuja Teaching Hospital, Gwagwalada 3. University College Hospital, Ibadan | Drug | Approved | 05/05/2017 | completed | Inspection Conducted | Routine | Notice of findings sent out to PI. |
| 42 | Investigation of Rheumatic AF Treatment Using Vitamin K antagonists, Rivaroxaban or Aspirin Studies (INVICTUS Trials) | INVICTUS Trials | Phase 3; | Dr. Okechwukwu S. Ogah | Dr. Okechwukwu S. OgaH | Division of cardiology, Department of medicine, University College Hospital, Queen Elizabeth road, Ibadan, POSTCODE 200212, Ibadan, Oyo state | 28/04/2017 | Hamilton Health Science, Hamilton, Ontario, Canada | Population Health Reseach Institute DBCVSRI, 237 Barton Street East Hamilton, Ontario, Canada L8L 2X2 | 1. Aminu Kano Teaching Hospital, Kano 2. University College Hospital, Ibadan 3. University of Nigeria Teaching Hospital, Ituku Ozalla 4. Ladoke Akintola University Teaching Hospital, Ogbomoso 5. Job University Teaching Hospital, Jos 6. Ahmadu Bello University Teaching Hospital, Zaria 7. Federal Medical Centre Abeokuta 8. Lagos University Teaching Hospital (LUTH), Idi-araba, Lagos 9. Delta State University Teaching Hospital, Oghara, Delta State | Drug | Approved | 25/07/2017 | On going | Inspection Conducted | Routine | Notice of findings sent out to PI. |
| 43 | Evaluation of the addition of moringa oleifera as a nutritional supplement on the anthropometric, viral load and CD4 counts of adult HIV patients on antiretroviral therapy in Nigeria | Moringa Oleifera | Phase 3; | Aisha Gambo | Aisha Gambo | No 5A, Dr Bala Muhammad Road, Kano, Nigeria | 24/05/2017 | University of Kwazulu-Natal, Department of Public Health Medicine | Department of Public Health Medicine, University of Kwazulu-Natal, 2nd floor, George Campbell Building, Durban, South Africa | 1. S.S Wali Virology Clinic, Aminu Kano Teaching Hospital (AKTH) Kano, Nigeria | Drug | Approved | 17/08/2017 | Completed | Inspection onducted (22/10/2018) | Routine | Notice of Findings sent to PI |
| 44 | A Phase 3, Double-blind, randomized, placebo-controlled, multicentre study of GBT 440 administered orally to patients with Sickle Cell Disease. | GBT440 | Phase 3; | Prof. Iheanyi Okpala 08025453354 iheanyi.okpala@unn.edu.n | Prof Ifeanyi Okpala | Institute of Molecular Medicine and Infectious Diseases, College of Medicine, University of Nigeria | 19/06/2017 | Global Blood Therapeutics | 400 East Jamie Court, Suite 101, South San Francisco , CA 94080, University State of America | Institute of Molecular Medicine and Infectious Diseases, College of Medicine, University of Nigeria, Ituku Ozalla, Enugu | Drug | Approved | 09/11/2017 | Suspended | Conducted | Routine | Request for clarification and action taken by sponsor was sent to the Contract Research Organisation |
| 45 | A multi-country, multi-centre, two arm, parallel, double blind, placebo controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low resource countries to improve newborn outcome | ACTION-1 Trial | Phase 3; | Prof. Oluwafemi Kuti | Prof. Oluwafemi Kuti | Department of Obstetrics & Gynecology, University College Hospital, Ibadan | 06/09/2017 | World Health Organization | Department of Reproductive Health and Research, Avenue Appia 20 12111 Geneva 27, Switzerland | 1. University College Hospital, Ibadan 2. Mother and Child Hospital, Akure 3. State Specialist Hospital, Akure 4. Nyanya General Hospital, Abuja 5. Kubwa General Hospital, Abuja 6. Lagos state University Teaching Hospital, Ikeja 7. Lagos Island Maternity Hospital, Lagos | Biologics | Approved | 09/01/2018 | completed | conducted | Routine | Notice of findings sent out to PI. Complied and met minimum regulatory requirements |
| 46 | A multi-country, multi-centre, two arm, parallel, double blind, placebo- controlled, randomized trial of antenatal corticosteriods for women at risk of imminent birth in the late preterm period in hospitals in low resource countries to improve newborn outcomes | ACTION II Trial | Phase 3; | Dr Adejumoke Idowu Ayede | Prof. Oluwafemi Kuti | Department of Pediatrics, University College Hospital, Ibadan | 06/09/2017 | Department of Reproductive Health & Research, World Health Organisation | Avenue Appia 20 1211 Geneva 27 Switzerland | 1. University College Hospital, Ibadan 2. Mother & Child Hospital, Akure 3. State Specialist Hospital, Akure 4. Nyanya General Hospital, Abuja 5. Lagos Island Maternity Hospital, Lagos 6. Kubwa General Hospital, Abuja 7. Lagos State University Teaching Hospital, Ikeja | Drug | Approved | 09/01/2018 | ongoing | Inspection Conducted | Routine | Notice of findings sent out to PI. |
| 47 | A Multicentre, Double blind, Randomized, parallel group, clinical trial to compare the sexual pleasure, performance, acceptability and safety of Graphene incorporated natural rubber latex condoms and natural rubber latex compounds in healthy humans. | Xcene Research Ltd | 11/02/2019 | The George Institute for Global Health | 1. University of Ilorin Teaching Hospital (UITH), Ilorin. 2. Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, 3. Lagos University Teaching Hospital (LUTH), Lagos 4. Jos University Teaching Hospital (JUTH), Jos 5. University College Hospital (UCH), Ibadan | Approved | 26/09/2019 | GCP inspection not conducted | NA | NA | |||||||
| 48 | A Multicentre, Double blind, Randomized, parallel group, clinical trial to compare the sexual pleasure, performance, acceptability and safety of Graphene incorporated natural rubber latex condoms and natural rubber latex compounds in healthy humans. | Graphene condom study | Phase 3; | Xcene Research Ltd | Dr Esther Ohihoin | 15, Ogulana Street, off Allen Avennue, Ikeja, Lagos | 11/02/2019 | The George Institute for Global Health, | Level 10, King George V Building, 83-117 Missenden Road, Camperdown WSW 2050. | 1. University of Ilorin Teaching Hospital (UITH), Ilorin. 2. Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, 3. Lagos University Teaching Hospital (LUTH), Lagos 4. Jos University Teaching Hospital (JUTH), Jos 5. University College Hospital (UCH), Ibadan | Medical Device | Approved | 26/09/2019 | completed | Conducted | Routine | Notice of Inspection sent to PI(Dr Gregory, Dr Esther) |
| 49 | A Multicentre, Double blind, Randomized, parallel group, clinical trial to compare the sexual pleasure, performance, acceptability and safety of Graphene incorporated natural rubber latex condoms and natural rubber latex compounds in healthy humans. | Xcene Research Ltd | 11/02/2019 | The George Institute for Global Health | 1. University of Ilorin Teaching Hospital (UITH), Ilorin. 2. Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, 3. Lagos University Teaching Hospital (LUTH), Lagos 4. Jos University Teaching Hospital (JUTH), Jos 5. University College Hospital (UCH), Ibadan | Approved | 26/09/2019 | GCP inspection not conducted | NA | NA | |||||||
| 50 | A Phase IIIB/IV Randomized Open-label Trial Comparing Dolutegravir with Predetermined Nucleosides Versus Recommended Standard of Care ART R regimens in Patients with HIV-1 Infection Failing First Line Therapy | The Institute of Human Virology-IHVN | 20/03/2019 | University of New South Wales | 1. University of Abuja Teaching Hospital, Gwagwalada, Area Council, Abuja 2. National Hospital Abuja, 265 Independence Avenue, CBD, Abuja | Approved | Not provided | GCP Inspection conducted at all the two sites | Routine | Notice of Findings Sent to PI | |||||||
| 51 | Stroke Prevention In Young Adults with Sickle Cell Anaemia | Aminu Kano Teaching Hospital | 24/04/2019 | National Institute of Health | 1. Aminu Kano Teaching Hospital | Approved | 31/12/2019 | GCP Inspection not conducted | NA | NA | |||||||
| 52 | An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel group, randomized controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill (Triple pill) strategy on top of standard of care, on the on time to first occurrence of recurrent stroke in patients with a history of acute stroke due to intracerebral hemorrhage | Triple therapy prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) | Phase 3; | Adebukunola Telufusi. Xcene Research Ltd | Prof. Kolawole Wahab | 15, Ogundana Street, off Alen Avenue, Ikeja Lagos | 16/07/2019 | The George Institute for Global Health | Level 10,King George V Building, 83117 Missenden Rd, Campdown NSW 2050 Ausralia. | 1. Neurology Unit, Dept. of Medicine, University of Ilorin Teaching Hospital (UITH), Ilorin. 2. Dept. of Medicine, Ahmadu Bello University Teaching Hospital (ABUTH), Zaria. 3. Neurology Unit, Dept. of Medicine, Lagos University Teaching Hospital (LUTH), Idi-Araba, Lagos. 4. Neurology Division , Dept. of Internal Medicine, Jos University Teaching Hospital (JUTH), Jos. 5. Neuroscience and Ageing Research Unit, Dept. of Medicine, University College Hospital (UCH), Ibadan. | Drug | Approved | 26/09/2019 | Ongoing | Conducted on 25th and 26 th March 2025 | Routine | Notice of Findings sent to the PI |
| 53 | Assessing Response to neo-adjuvant Taxotere and Trastuzumab in Nigerian women with HER2-positive breast cancer | HER2- | Prof. (Mrs) Peace Babalola | 17/07/2019 | University of Chicago, Bilogical Science Division/University of Chicago Medical Center | 1. Lagos State University Teaching Hospital, Ikeja, Lagos State 2. Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) Ile Ife 3. Lagos University Teaching Hospital LUTH 4. University College Hospital, Ibadan | Approved | 15/08/2019 | GCP Inspection not conducted | NA | NA | ||||||
| 54 | Assessing Response to neo-adjuvant Taxotere and Trastuzumab in Nigerian women with HER2-positive breast cancer | ARETTA | Phase 3; | Prof. (Mrs) Peace Babalola | Dr Atara Ntekim | Pharmacy Department, University College Hospital Ibadan | 17/07/2019 | University of Chicago, Bilogical Science Division/University of Chicago Medical Center | University of Chicago Center for Global Health (UC CGH), 60637 Chicago, USA | 1. Lagos State University Teaching Hospital, Ikeja, Lagos State 2. Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) Ile Ife 3. Lagos University Teaching Hospital LUTH 4. University College Hospital, Ibadan | Drug | Approved | 15/08/2019 | on-going | Scheduled but not conducted | NA | Not applicable |
| 55 | Traxenamic acid for reducing postpartum bleeding in women with anaemia: an international, randomized, double blind, placebo controlled trial. | WOMAN-2 | Phase 3; | Prof Oladapo Olayemi | Dr Folasade Adenike Bello | Department of Obstetrics & Gynecology, University College Hospital, Ibadan | 28/10/2019 | London School of Hygiene and Tropical Medicine | Keppel Street, London, WC1E 7HT | 1. Mother and Child Hospital, Akure 2. Mohammed Abdullahi Wase Specialist Hospital, Kano 3. Adeoyo Maternity Teaching Hospital, Ibadan | Drug | Approved | 30/12/2019 | Ongoing | Scheduled but not conducted yet | NA | NA |
| 56 | Assessing the Feasibility of Utilizing an Automated Lung Ultrasound (US) Platform among III RV 446/WRAIR 2383 Severe Infectious Disease: Surveillance, Detection, Risks and Consequences in West Africa Participants in Lagos, Nigeria | U.S Military HIV Research Program Walter Reed Army Institute of Research, Embassy of the United States of Amirica, Abuja, Nigeria | 29/10/2019 | Defence Advance Research Projects Agency (DARPA), Walter Reed Army Institute of Research | 1. 68, Nigerian Army Reference Hospital, Lagos 2. General Hospital, Ikorodu, Lagos | Approved | 02/01/2020 | GCP not conducted | NA | NA | |||||||
| 57 | A Phase IIIB/IV Randomized Open-label Trial Comparing Dolutegravir with Predetermined Nucleosides Versus Recommended Standard of Care ART R regimens in Patients with HIV-1 Infection Failing First Line Therapy | D2EFT: Dolutegravir and Darunavir Evaluation in Adults Failing Therapy | Phase 3; | The Institute of Human Virology-IHVN | Dr Eriobu Nnakelu | Pent House, Maina Court, Plot 252, Herbert Macauly Way, CDB, Garki Way, Abuja | 20/03/2019 | University of New South Wales | The Kirby Institute, University of New South Wales | 1. University of Abuja Teaching Hospital, Gwagwalada, Area Council, Abuja 2. National Hospital Abuja, 265 Independence Avenue, CBD, Abuja | Drug | Approved | 15/11/2020 | On-going | Conducted | Routine | Notice of findings sent out to PI. |
| 58 | ClustEr randomised Trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low and middle income counties (LMICs) | ChEETAH | Phase 3; | NIHR GSU Lagos Hub, College of Medicine, University of lagos | Prof.Ademuyiwa | Paedriatic Unit, College of Medicine, University of Lagos | 17/02/2020 | University of Birmingham | Research Governance Team University of Birmingham, Birmingham, B152TT | ROOM 309 Department of Surgery, College of Medicine, University of Lagos, Idi-araba, Lagos State | Procedure | Approved | 27/03/2020 | Ongoing | Inspection not Conducted | NA | NA |
| 59 | Pragmatic multicentre Factorial randomized controlled trial testing measures of reducing surgical site infection in low and middle income countries | FALCON Trial | Phase 3; | NIHR GSU Lagos Hub, College of Medicine, University of Lagos | Prof Ademuyiwa | Paediatric Surgery Unit, Department of Surgery, Faculty of Clinical Sciences, CMUL | 17/02/2020 | University of Birmingham | Research Governance Team, University of Birmingham, Birmingham, B15 2TT | Lagos University Teaching Hospital | Procedure | Approved | 27/03/2020 | completed | Inspection Conducted | Routine | Notice of findings sent out to PI. |
| 60 | SA | Lagos State Government | 09/04/2020 | Lagos State Government | 1.. Lagos Mainland Infectious Diseases Hospital Yaba, Lagos State, Nigeria 2. Onikan Stadium Isolation Center. 3. . Landmark Events Center, Water corporation wa, IV, Lagos. 4. Lekki Travel Inn Hotel, opposite Mega Chicken, Lekki. 5.Gbagada General Hospital, Gbagada | Approved | 12/05/2020 | GCP Inspection not conducted | NA | NA | |||||||
| 61 | A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL ASSESSING THE EFFICACY AND SAFETY OF IVERMECTIN IN COVID- 19 (IVERCOVID) STUDY | IVERCOVID | 2B/3 | Dr Femi alakaloko | Prof. Olufemi Babalola | Consultant Paediatric Surgeon, Department of Surgery, Lagos Universtity Teaching Hospital. | 08/05/2020 | Federal Government of Nigeria | Abuja | Lagos University Teaching Hospital /CMUL | Ivermectin | Approved | 17/05/2020 | Completed | Inspection not conducted | NA | NA |
| 62 | An International Randomized Trial of Additional Treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care | SOLIDARITY | 3 | Dr. Okatubo Geofrey. | Prof Abdulrazaq G. Habib | 11th floor, Department of Health Planning Research & Statistics, Federal Ministry of Health, Abuja | 20/06/2020 | WHO and FMOH, Nigeria | 11th floor, Department of Health Planning Research & Statistics, Federal Ministry of Health, Abuja | 1. Ikenne isolation Centre Ogun State. 2.National Hospital, Abuja. 3.Kwanar Dawaki, Kano. 4. University of Maiduguri Teaching Hospital, Maiduguri. 5.University of Benin Teaching Hospital, Benin City, Nigeria. 6. University of Benin Teaching Hospital, Benin City, Nigeria. 7. IDH Amanawa, Sokoto. 8. Ahmadu Bello University Teaching Hospital(ABUTH), Shika-Zaria. 9.OOUTH Isolation Centre, Ogun. 10. Muhammadu Buhari Hospital Isolation Center. 11. University of Port Harcourt Teaching Hospital. | Remdesivir, Interferon beta and Acalabritinib | Approved | 15/08/2020 | Completed | Inspection not conducted | NA | NA |
| 63 | An international randomised trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care | Dr Okatubo Geoffrey | 20/06/2020 | Lagos State Government | Isolation Centre, Infectious Disease Hospital (IDH), Yaba, Lagos. | Approved | 15/08/2020 | Inspection not conducted | NA | NA | |||||||
| 64 | An International Randomized Trial of Additional Treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care | Dr. Okatubo Geofrey. | 20/06/2020 | WHO and FMOH, Nigeria | 1. Ikenne isolation Centre Ogun State. 2.National Hospital, Abuja. 3.Kwanar Dawaki, Kano. 4. University of Maiduguri Teaching Hospital, Maiduguri. 5.University of Benin Teaching Hospital, Benin City, Nigeria. 6. University of Benin Teaching Hospital, Benin City, Nigeria. 7. IDH Amanawa, Sokoto. 8. Ahmadu Bello University Teaching Hospital(ABUTH), Shika-Zaria. 9.OOUTH Isolation Centre, Ogun. 10. Muhammadu Buhari Hospital Isolation Center. 11. University of Port Harcourt Teaching Hospital. | Approved | 15/08/2020 | GCP Inspection not conducted | NA | NA | |||||||
| 65 | A multicenter, open-label, single-arm study to evaluate the PK, safety, tolerability and efficacy of a new artemether lumefantrine (2.5 mg:30 mg) dispersible tablet in the treatment of infants and neonates <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria | Adetokunbo Adekalu | 05/06/2020 | NOVARTIS AG | Department of Pediatrics, College of Medical Sciences, University of Calabar, Nigeria. | Approved | 21/09/2020 | GCP Inspection conducted | Routine | Notice of Findings Sent to PI | |||||||
| 66 | An international Multicenter, adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the safety, tolerability and efficacy of Anti—Corona Virus Hyperimmune Intravenous Immunoglobulin for the treatment of Adult Hospitalized Patients at onset of Clinical Progression of COVID 19 | Dr Nnakelu Eriobu | 29/09/2020 | IHVN | 1. National Hospital, Abuja 2. University of Abuja Teaching Hospital, Abuja | Approved | 28/10/2020 | GCP Inspection not conducted | NA | NA | |||||||
| 67 | Open Label, Randomized Controlled Trial of the Safety and Efficacy of Hydroxychloroquine and Chloroquine Phosphate for the Treatment of Persons Infected with Coronavirus Disease (COVID - 19) in Nigeria. | NA | 2 | Prof. Babatunde Salak | Prof. Babatunde Salak | Nigerian Institute of Medical Research | 27/05/2020 | Nigeria Institute of Medica Research, | 6, Edmund Cresent Road, Yaba, | Nigerian Institute of Medical Research | Chloroquine sulfate, Hydroxychloroquine | Approved | NA | Completed | Inspection not conducted | NA | NA |
| 68 | Aspirin, Losartan and simvastatin in Hospitalized COVID-19 patients: a multinational randomised open-label factorial trial | CRASH-19 | 2 | Prof Temitayo Shokunbi | Dr Olukemi Adekambi | College of Neurosurgery, University College Hospital, Ibadan, Nigeria | 28/05/2020 | London School of Hygiene and Tropical Medicine (LSHTM | Keppel street,London WC1E 7HT | 1..Department of internal Medicine, Abubakar Tafawa Balewa University, Hospital Road, Off Yandoka Street., 2..Department of Pediatrics, Ahmadu Bello University Teaching Hospital 3.Department of internal medicine, Federal Medical Centre, Katsina Murtala Muhammad way, Katsina.4.Infectious Disease Unit, Infectious Disease Centre, Sobi Specialist Hospital, Ilorin.5.Institute of Lassa Fever Research and Control, Irrua Specialist 6.Department of Surgery, LAUTECH teaching Hospital, Oshogbo 7. Department of Internal Medicine, Lagos University Teaching Hospital, Lagos.• akasephraim@yahoo.com 8.Department of Internal Medicine, National Hospital Abuja.9. Department of Medicine, Olabisi Onabanjo University Teaching Hospital .10.Department of Medicine, University College Hospital.11.Department of internal Medicine, University of Uyo Teaching Hospital.12.Department of Epidemiology and Disease Control, Akure, Ondo State.13.Department of Medicine, Infectious Disease Hospital Kano.14.Department of Medicine, Federal Teaching Hospital, Gombe.15. Department of Internal Medicine, Bayero University College of Health Sciences.16.Muhammadu Buhari Specialist Hospital, Kano.17. Department of Internal Medicine, University of Maiduguri Teaching Hospital. | Aspirin, Losartan, Simvastatin | Approved | ongoing | Inspection not conducted | NA | NA | |
| 69 | Aspirin, Losartan and simvastatin in Hospitalized COVID-19 patients: a multinational randomised open-label factorial trial | Prof Temitayo Shokunbi | 28/05/2020 | London School of Hygiene and Tropical Medicine (LSHTM | 1..Department of internal Medicine, Abubakar Tafawa Balewa University, Hospital Road, Off Yandoka Street., 2..Department of Pediatrics, Ahmadu Bello University Teaching Hospital 3.Department of internal medicine, Federal Medical Centre, Katsina Murtala Muhammad way, Katsina.4.Infectious Disease Unit, Infectious Disease Centre, Sobi Specialist Hospital, Ilorin.5.Institute of Lassa Fever Research and Control, Irrua Specialist 6.Department of Surgery, LAUTECH teaching Hospital, Oshogbo 7. Department of Internal Medicine, Lagos University Teaching Hospital, Lagos.• akasephraim@yahoo.com 8.Department of Internal Medicine, National Hospital Abuja.9. Department of Medicine, Olabisi Onabanjo University Teaching Hospital .10.Department of Medicine, University College Hospital.11.Department of internal Medicine, University of Uyo Teaching Hospital.12.Department of Epidemiology and Disease Control, Akure, Ondo State.13.Department of Medicine, Infectious Disease Hospital Kano.14.Department of Medicine, Federal Teaching Hospital, Gombe.15. Department of Internal Medicine, Bayero University College of Health Sciences.16.Muhammadu Buhari Specialist Hospital, Kano.17. Department of Internal Medicine, University of Maiduguri Teaching Hospital. | Approved | Not provided | GCP Inspection not conducted | NA | NA | |||||||
| 70 | Pharmacokinetics, tolerability and safety of favipiravir alone and in combination with ribavirin for the treatment of Lassa Fever: A randomized controlled open label phase II clinical trial | Dr Cyril Erameh | 08/06/2020 | Bernhard Nocht Institute for Tropical Medicine | 1. Irrua Specialist Teaching Hospital (ISTH), KM 87 Benin Auchi Road, Irrua, Nigeria. 2. Federal Medical Centre, Owo, Ondo State | Approved | Not provided | GCP Inspection not conducted | NA | NA | |||||||
| 71 | Pharmacokinetics, Tolerability and Safety of Favipiravir alone and in combination with Ribavirin for the treatment of Lassa fever: A randomized controlled open label phase II clinical trial | SAFARI | 2 | Notice of findings sent out to PI. | Dr Peter Akhideno | Irrua Specialist Teaching Hospital,Km 87 Benin Auchi road, Irrua, Nigeria | 11/06/2020 | Bernhard Nocht Institute for Tropical Medicine | Bernhard Nocht Institute for Tropical Medicine. Bernhard-Nocht street. 74 D-20359 Hamburg, Germany. | 1) Irrua Specialist Teaching Hospital, Irrua, Nigeria. 2) Federal Medical Center of Owo, Ondo state, Nigeria. | Drugs (Favipiravir and Ribavirin) | Approved | 03/08/2021 | ongoing | GCP Inspection not conducted | NA | NA |
| 72 | Pharmacokinetics, Tolerability and Safety of Favipiravir alone and in combination with Ribavirin for the treatment of Lassa fever: A randomized controlled open label phase II clinical trial | Dr Cyril Erameh | 11/06/2020 | Bernhard Nocht Institute for Tropical Medicine | 1) Irrua Specialist Teaching Hospital, Irrua, Nigeria.2) Federal Medical Center of Owo, Ondo state, Nigeria. | Approved | 08/03/2021 | GCP Inspection not conducted | NA | NA | |||||||
| 73 | A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Clinical Trial Of The Safety And Efficacy Of Convalescent Plasma For The Treatment Of Covid-19 In Hospitalized Patients In Lagos State | Dr Hussein Abdur-Razzaq | 26/10/2020 | Lagos State Government | Isolation Centre, Infectious Disease Hospital (IDH), Yaba, Lagos. | Not Approved | 08/03/2021 | NA | NA | NA | NA | ||||||
| 74 | Efficacy and safety of Mojeagaherbal remedy in combination with conventional oral iron therapy for correcting anemia in gynecological and obstetrics patients: a pilot randomized clinical trial | NA | 1 | Mr Monday Ojeaga Alugeh | Dr George Uchenna Eleju | Flat 75, Block H, Federal Housing Estate, Benin Auchi Road, Ikpoba Hill, Benin City, Nigeria | 27/11/2020 | Mr Monday Ojeaga Alugeh | Flat 75, Block H, Federal Housing Estate, Benin Auchi Road, Ikpoba Hill, Benin City, Nigeria | Nnamdi Azikwe University | Mojeagaherbal remedy | Approved | 15/05/2021 | Completed | NA | NA | NA |
| 75 | A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19 | Professor Elijah Sokomba | 30/11/2020 | NEIMETH PHARMACEUTICALS | 1. University of Abuja Teaching Hospital, Gwagwalada, Area Council, Abuja | Approved | 12/07/2021 | GCP Inspection not conducted | NA | NA | |||||||
| 76 | A randomized, open label trial to investigate the efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of COVID-19: a pilot study | NACOVID | 2 | Dr Adeniyi Olagunju | Dr Adeniyi Olagunju | Obafemi Awolowo University, Ile-Ife, Osun State | 25/12/2020 | Obafemi Awolowo University, Ile-Ife, Osun State | Obafemi Awolowo University, Ile-Ife, Osun State | Obafemi Awolowo University, Ile-Ife, Osun State | Nitazoxanide plus atazanavir/ritonavir | Approved | 5th February 2021 | On-going | NA | NA | NA |
| 77 | Efficacy and safety of Mojeagaherbal remedy in combination with conventional oral iron therapy for correcting anemia in gynecological and obstetrics patients: a pilot randomized clinical trial | Mr Monday Ojeaga Alugeh | 15/01/2021 | MOJEAGA VENTURES | . Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Amaku, Awka, Anambra 2. Nnamdi Azikwe University Teaching Hospital, Nnewi 3. Enugu State University Teaching Hospital, Enugu | Approved | 15/05/2021 | GCP Inspection were conducted at two sites | Routine | Notice of Findings Sent to PI | |||||||
| 78 | A multi-centre randomised controlled non-inferiority trial to compare the efficacy, safety and tolerability of Triple Artemisinin-based Combination Therapies versus first-line ACTs + placebo for the treatment of uncomplicated Plasmodium falciparum malaria in Africa | Prof Olugbenga A. Mokuolu, | 18/02/2021 | Prof Olugbenga A. Mokuolu, | 1. Ajikobi Comprehensive Health Centre, Ilorin | Approved | 27/04/2021 | GCP not Inspection conducted | NA | Notice of Findings Sent to PI | |||||||
| 79 | A multi-centre randomised controlled non-inferiority trial to compare the efficacy, safety and tolerability of Triple Artemisinin-based Combination Therapies versus first-line ACTs + placebo for the treatment of uncomplicated Plasmodium falciparum malaria in Africa | DETACT | 3 | Dr Mohd Baba Abdulkadir | Prof Olugbenga A. Mokuolu, | Centre for Malaria and Other Tropical Diseases Care, University of Ilorin Teaching Hospital, Ilorin, Kwara State | 18/02/2021 | Ajikobi Comprehensive Health Centre Ilorin, Kwara State | drugs | approved | 27/04/2021 | ongoing | GCP not Inspection conducted | NA | NA | ||
| 80 | A multicenter, open-label, single-arm study to evaluate the PK, safety, tolerability and efficacy of a new artemether lumefantrine (2.5 mg:30 mg) dispersible tablet in the treatment of infants and neonates <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria | NA | 3 | Adetokunbo Adekalu | Prof Martins Meremikwo | Novartis Nigeria Limited, Regulatory Affairs English West Africa, Global Drug Development, Landmark House, 3rd Floor, 52/54, Isaac John Street, Ikeja, Lagos | 25/02/2021 | Novartis Nigeria Limited, Regulatory Affairs English West Africa, Global Drug Development | Novartis Nigeria Limited, Regulatory Affairs English West Africa, Global Drug Development, Landmark House, 3rd Floor, 52/54, Isaac John Street, Ikeja, Lagos | College of | artemether lumefantrine | Approved | 21/09/2021 | On going | NA | NA | NA |
| 81 | Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): an open label, randomized controlled trial | Professor Bosede B. Afolabi, | 08/04/2021 | Bill & Melinda Gate Foundation | 1. Lagos University Teaching Hospital, Lagos 2. Lagos Island Maternity Hospital, Lagos 3.Mother and Child, Amuwo Odofin, Lagos 4. Simpson Primary Health Centre, Lagos 5. Iwaya Primary Health Centre, Yaba, Lagos 6. Aminu Kano Teaching Hospital, Kano 7. Sheikh Jeddah General Hospital, Kano 8. Nuhu Bammali Maternity Hospital, Kano 9. Kumbotsu Comprehensive Primary Health Centre, Kumbotsu, Kano. 10. Sharada Primary Health Centre, Kano | Approved | 23/04/2021 | GCP Inspections were conducted at three sites | Routine | Notice of Findings Sent to PI | |||||||
| 82 | Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): an open label, randomized controlled trial | IVON | 3 | Professor Bosede B. Afolabi, | Professor Bosede B. Afolabi, | Department of Obstetrics and Gynecology,College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria | 04/08/2021 | Professor Bosede B. Afolabi | Department of Obstetrics and Gynecology,College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria | 1. Lagos University Teaching Hospital, Idi-Araba, Lagos 2. Lagos Island Maternity Hospital, Lagos 3. Mother and Child Centre, Amuwo-odofin, Lagos 4. Simpson Primary Health Centre, Ebute-Metta, Lagos 6. Iyawa Primary Health Centre, Yaba, Lagos 7. Sheikh Jeddah General Hospital, Kano 8. Nuhu Bammali Maternity Hospital, Kano 9. Kumbotsu Comprehensive Primary Health Centre, Kumbotsu, Kano 10. Sharada Primary Health Centre. kano | drugs | approved | 23/04/2021 | on going | Conducted Inspection conducted on 2 nd and 3rd April, 2025 | Routine | Notice of findings sent out to PI. Complied and met minimum regulatory requirements. CAPA review ungoing |
| 83 | A Phase 3 Randomized, Double Bind, Placebo-Controlled study of Voxelotor (GBT 440-032) in Pediatric Patients with Sickle Cell Disease (HOPE Kids 2) | Ms Adebukunola Telufusi | 06/08/2021 | Global Blood Therapeutics | 1. Lagos University Teaching Hospital 2. University College Hospital, Ibadan. 3. Aminu Kano Teaching Hospital,Kano 4. Barau Dikko Teaching Hospital, Kaduna | Approved | 29/07/2021 | GCP Inspections conductedall sites | Routine | Notice of Findings Sent to PI | |||||||
| 84 | A Phase 3 Randomized, Double Bind, Placebo-Controlled study of Voxelotor (GBT 440-032) in Pediatric Patients with Sickle Cell Disease (HOPE Kids 2) | HOPE KIDS 2 | 3 | Ms Adebukunola Telufusi | Prof Iheanyi Okpala | Xcene Research Limited, 15 Ogundana Street, Off Allen Avenue, Ikeja, Lagos | GBT/Pfizer | University Of Minnesota, Minneapolis, MN 55455, United States | 1. Lagos University Teaching Hospital (LUTH), Ishaga Rd, Idi-Araba, Lagos,Lagos State 2. University College Hospital (UCH),Ibadan, Oyo state 3. Aminu Kano Teaching Hospital (AKTH),No 2 Zaria Road, Kano,Kano State 4. University of Nigeria Teaching Hospital, 1, UNTH road, Ituku/Ozalla, Enugu state 5. Barau-Dikko Teaching Hospital, Lafiya road, city centre, Kaduna state | Voxelotor | Approved | 29/07/2021 | On-going | Conducted | routine | Notice of findings sent out to PI. Complied and met minimum regulatory requirements | |
| 85 | The Efficacy and Safety of IHP [InterCEDD Health Products] Detox Tea [a Special Blend of Andrographis paniculata;Burm F., Garcinia kola Heckel and Psidium guajava L.] for the Treatment of Coronavirus Disease 2019 [COVID-19]: A Pilot Randomized Clinical Trial. | IHP DETOX | 2 | Professor Elijah Sokomba | Prof Elijah Sokomba | No 1 JB Leton close, Off Dan Isokrari close, Off Abdullahi Ibrahim Crescent. Opposite Haribina Hotel, Utako District. Abuja, FCT | 25/06/2020 | INTERCEDD HEALTH PRODUCTS LIMITED in collaboration with Neimeth International Pharmaceuticals Plc | BDG House, No.1 J.B. Leton Close, Off Dan Isokrari Close, Off Abdullahi Ibrahim Crescent, Opposite Haribina Hotel, Utako District, Abuja, Federal Capital Territory | 1. College of Medicine, Lagos University Teaching Hospital (LUTH), Idi-Araba, Lagos. | Herbal tea | Approval | 29/05/2021 | Completed | Conducted | Routine | Notice of findings sent out to PI. Complied and met minimum regulatory requirements |
| 86 | The Efficacy and Safety of IHP [InterCEDD Health Products] Detox Tea [a Special Blend of Andrographis paniculata;Burm F., Garcinia kola Heckel and Psidium guajava L.] for the Treatment of Coronavirus Disease 2019 [COVID-19]: A Pilot Randomized Clinical Trial. | Professor Elijah Sokomba | 25/06/2020 | INTERCEDD HEALTH PRODUCTS LIMITED in collaboration with Neimeth International Pharmaceuticals Plc | 1. College of Medicine, Lagos University Teaching Hospital (LUTH), Idi-Araba, Lagos. | Approved | 28/09/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 87 | Evaluation of Nemazyn efficacy and safety in COVID 19 Patients | NEMAZYN | 2 | Dr Ali Johnson Onoja | Dr Ali Johnson Onoja | Plot 7 Ellicott Street, Kubwa Extension 3, Kubwa, Abuja FCT. | 21/07/2020 | Clitriad Pharma Service Limited | Plot 7 Ellicott Street, Kubwa Extension 3, Kubwa, Abuja FCT. | University of Nigeria Teaching Hospital Enugu ,Nsukka | Nemazyn | Rejected | NA | NA | GCP Inspection not conducted | NA | NA |
| 88 | An Open-Label Clinical Trial Of Anti-Viral Efficacy And Immune-Boosting Effects Of Oral Treatment With Black Seed Oil In Patients With Coronavirus Disease (Covid-19) | 3 | Dr Hussein Abdur-Razzaq | Dr Hussein Abdur-Razzaq | Lagos State Ministry of Health, Block 4,Lagos State Ministry of Health Alausa, lagos | 26/10/2020 | Lagos State Ministry of Health, Block 4,Lagos State Ministry of Health Alausa, lagos | Lagos State Ministry of Health, Block 4,Lagos State Ministry of Health Alausa, lagos | NA | Black seed oil | Under review | NA | Rejected | GCP Inspection not conducted | NA | NA | |
| 89 | COVIP- PLUS ANTISNAKE VENOM VACCINE DOUBW BLIND RANDOMISED CONTROL PHASE 1 TRIAL IN NIGERIA | Professor Aboi JK Madaki | 10/11/2020 | Africa Centre of Excellence in Phytomedicine, Research and Development | JUTH Comprehensive Health Centre Zamko | Not Approved | 14/07/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 90 | Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 ( PROTECT-Surg) | Prof. Adesoji Ademuyiwa, | 25/01/2021 | National Institute of Health Research, London | Lagos University Teaching Hospital | Approved | 20/07/2021 | GCP Inspection conducted | Routine | Notice of Findings Sent to PI | |||||||
| 91 | Evaluation of the inhibitory activities of silymarin against SARS-CoV-2 | Dr Nathan Y. Shehu | 25/01/2021 | Not provided | Jos University Teaching Hospital, Jos. 2. Plateau State Specialist Hospital, Plateau | Approved | 27/04/2021 | GCP Inspection not conducted | NA | NA | |||||||
| 92 | THERAPEUTICS FOR INPATIENT TREATMENT WITH COVID-19; A MULTICENTER, ADAPTIVE, RANDOMIZED. BLINDED, CONTROLLED. TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR HOSPITALIZED PATIENTS WITH COVID-19 (TICO) | TICO | 3 | Dr Eriobu Nnakelu | Dr Eriobu Nnakelu | Institute of Human Virology, Penthouse, Maina Court, Plot 252, Herbert Macaulay Way, Central Business District, Abuja | 17/05/2021 | University Of Minnesota, Minneapolis, MN 55455, United States | University Of Minnesota, Minneapolis, MN 55455, United States | University of Abuja Teaching Hospital, Abuja | Drug | Approved | 17/05/2021 | Ongoing | conducted | Routine inspection/ 26/03/2024 | Met minimum regulatory requirements |
| 93 | Evaluation of a triple single-pill combination (triple pill)-based treatment protocol compared to the Nigeria hypertension treatment protocol for improving BP control in Nigeria. (VERONICA-Nigeria) | Dr Dike Ojji | 10/08/2021 | George Medicines Pty Limited | University of Abuja Teaching Hospital, Gwagwalada, Abuja | Approved | 01/10/2021. | GCP Inspection conducted | Routine | Notice of Findings Sent to PI | |||||||
| 94 | MANAGEMENT OF SEVERE ACUTE MALNUTRITION IN CHILDREN WITH SICKLE CELL DISEASE GREATER THAN FIVE (5) YEARS OF AGE LIVING IN NORTHERN NIGERIA” | Dr Shehu Abdullahi | 29/04/2021 | National Institute of Health | Aminu Kano Teaching Hospital, Kano 2. Murtala Muhammed Specialist Hospital, Kano | Approved | 19/04/2021 | GCP Inspection conducted | Routine | Notice of Findings Sent to PI | |||||||
| 95 | SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients (VATICO) | VATICO | Dr Nnakelu Eriobu | 15/08/2021 | IHVN | University of Abuja Teaching Hospital, Gwagwalada, Abuja | Approved | 06/12/2021. | GCP Inspection not conducted | NA | NA | ||||||
| 96 | Early Detection of Postpartum Haemorrhage and Treatment using the World Health Organization MOTIVE ‘First Response’ Bundle: A cluster Randomised Trial with Health Economic Analysis and Mixed- methods Evaluation | Not provided | 29/08/2021 | Not provided | 1. AMINU KANO TEACHING HOSPITAL KANO 2. BARAU DIKKO TEACHING HOSPITAL, KADUNA 3. RIVERS STATE UTH PORT-HARCOURT 4. FEDERAL MEDICAL CENTRE KATSINA 5. FMC AZARE, BAUCHI STATE 6. HAJIYA GAMBO SAWABA HOSPITAL ZARIA 7. ABU TEACHING HOSPITAL ZARIA 8. UNIVERSITY OF BENIN TEACHING HOSPITAL BENIN CITY 9. DUTSE GENERAL HOSPITAL, JIGAWA 10. TURAI UMARU YARADUA HOSPITAL KATSINA 11. BIRNINKUDU GH JIGAWA 12. SABO BAKINZUWO MATERNITY KANO 13. UNIMED TEACHING HOSPITAL ONDO 14. WAZIRI GIDADO GENERAL HOSPITAL KANO 15. CENTRAL HOSPITAL BENIN 16. RINGIM GENERAL HOSPITAL JIGAWA STATE 17. SIR YAHYA MEMORIAL HOSPITAL KEBBI 18. FMC KEBBI 19. UDU SOKOTO TEACHING HOSPITAL 20. ASYB SPECIALIST HOSPITAL ZAMFARA 21. UNIVERSITY OF ILORIN TEACHING HOSPITAL 22. JOS UNIVERSITY TEACHING HOSPITAL, JOS 23. UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL 24. FMC GUSAU, ZAMFARA STATE 25. KAZAURE GENERAL HOSPITAL JIGAWA STATE 26. GUMEL GENERAL HOSPITAL JIGAWA STATE 27. YUSUF DANTSOHO HOSPITAL KADUNA 28. SPECIALIST HOSPITAL SOKOTO 29. CENTRAL HOSPITAL WARRI, WARRI. 30. FMC YOLA, ADAMAWA STATE 31. SULEJA GENERAL HOSPITAL, NIGER STATE 32. NYANYA GENERAL HOSPITAL, ABUJA | Approved | 24/02/2022 | GCP Inspections schduled for three sites | Routine | Notice of Findings Sent to PI | |||||||
| 97 | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso-occlusive Crises, dated 15/06/2020. Protocol Inclacumab GBT2104-131 | Xcene Research Ltd | 03/08/2021 | Global Blood Therapeutics | 1. Barrau Dikko Teaching Hospital, Kaduna 2. Lagos University Teaching Hospital, Lagos 3. University of Nigeria Teaching Hospital, Enugu 4. Aminu Kano Teaching Hospital, Kano 5. University of Abuja Tecahing Hospital, Abuja. 6. University of Calabar Teaching Hospital, Calabar. | Approved | 17/12/2021. | GCP Inspection conducted at four sites | Routine | Notice of Findings Sent to PI | |||||||
| 98 | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso occlusive crisis (GBT 2104-131) | GBT 2104-131 | 3 | Excene Research | Dr Shehu Abdullahi | 15 Ogundana Street, Off Allen Avenue, Ikeja Lagos, Nigeria | 31/05/2021 | GBT/Pfizer Specialist | University Of Minnesota, Minneapolis, MN 55455, United States | 1.Department of Pediatrics, Aminu Kano Teaching Hospital, Kano. 2. Department of Medicine, Lagos University Teaching Hospital, Surulere, Lagos 3. Department of Hematology, University of Abuja Teaching Hospital. 4. Department of Hematology, University of Nigeria Teaching Hospital, Enugu 5. Department of Hematology, National Hospital, Abuja 6. Department of Pediatrics, College of Medical Sciences, University of Calabar, Nigeria 7. Barau Dikko Hospital, Kaduna 8. Ahmadu Bello University Teaching Hospital, Zaria, Kaduna. | Drug | Approved | 17/12/2021 | ongoing | Conducted | Routine inspection/ 20/03/2024 | Notice of Findings sent to PI |
| 99 | A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants with Sickle Cell Disease and Recurrent Vaso-occlusive Crises. | Xcene Research Ltd | 03/08/2021 | Global Blood Therapeutics | 1. Barrau Dikko Teaching Hospital, Kaduna 2. Lagos University Teaching Hospital, Lagos 3. University of Nigeria Teaching Hospital, Enugu 4. Aminu Kano Teaching Hospital, Kano 5. University of Abuja Tecahing Hospital, Abuja. 6. University of Calabar Teaching Hospital, Calabar. | Approved | 23/12/2021. | GCP Inspections conducted at three sites | Routine | Notice of Findings Sent to PI | |||||||
| 100 | A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older” | SANOFI VACCINE TRIAL | 3 | Dr Michael Iroezindu | Dr Michael Iroezindu | 7 Usuma Street, Maitama, Abuja, Nigeria | 16/07/2021 | SANOFI | 1. Clinical Research Centre (CRC) Walter Reed Program-Nigeria. 2. Centre for Clinical Trials, University of Nigeria, Nsukka 3. University College Hospital (UCH) Layi Ayanniyi Street, Ibadan 4. Lagos State University Teaching Hospital (LUTH) 5. Usman Danfodiyo University Teaching Hospital (UDUTH), Sokoto, Nigeria 6. Jos University Teaching Hospital (JUTH), Jos, Plateau state, Nigeria 7. Barau Dikko Teaching Hospital (BDTH), Kaduna, Nigeria | Vaccine | Approved | 15/11/2021 | approved but study did not commence | Approved study did not commence | NA | NA | |
| 101 | “An international randomized trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care” SOLIDARITY PLUS | SOLIDARITY PLUS | 2 | Dr Geoffrey Okatubo | Prof Abdulrazaq Habib | Federal Ministry of Health, Nigeria | 08/10/2021 | World Health Organization | World Health Organization | University College Hospital, Ibadan Isolation Centre, Infectious Disease Hospital, Lagos Isolation centre University of Abuja Teaching Hospital Isolation Centre, Lagos Mainland Hospital Isolation centres in Kano, Rivers, Oyo, sokoto and Kano states | Drug | Approved | 25/10/2021 | Completed | Conducted | Routine inspection/28-03-2024 | Notice of findings sent out to PI. Awaiting response |
| 102 | Preoperative respiratory care and outcomes for patients undergoing high risk abdominal surgery. A 2x2 factorial, international pragmatic randomized trial | Prof Adesoji Ademuyiwa | 03/03/2021 | National Institute of Health | Lagos University Teaching Hospital | Approved | 20/07/2021 | GCP Inspection conducted | Routine | Notice of Findings Sent to PI | |||||||
| 103 | An international randomized trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care” (SOLIDARITY PLUS TRIAL | Prof Habib Abdullahi | 05/08/2021 | WHO and FMOH, Nigeria | 1. ISOLATION CENTRE BAYERO UNIVERSITY, KANO 2. ISOLATION CENTRE UNIVERSITY OF ABUJA TEACHING HOSPITAL 3. ISOLATION CENTRE LAGOS MAINLAND HOSPITAL 4. ISOLATION CENTRE UNIVERSITY COLLEGE HOSPITAL, IBADAN 5. ISOLATION CENTRE, PORT HARCOURT, RIVERS STATE. 6. ISOLATION CENTRE UDUTH, SOKOTO | Approved | 23/10/2021 | GCP Inspection conducted at One site | Routine | Notice of Findings Sent to PI | |||||||
| 104 | Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): an open label, randomized controlled trial | Professor Bosede B. Afolabi, | 08/04/2021 | Bill & Melinda Gate Foundation | 1. Lagos University Teaching Hospital, Lagos 2. Lagos Island Maternity Hospital, Lagos 3.Mother and Child, Amuwo Odofin, Lagos 4. Simpson Primary Health Centre, Lagos 5. Iwaya Primary Health Centre, Yaba, Lagos 6. Aminu Kano Teaching Hospital, Kano 7. Sheikh Jeddah General Hospital, Kano 8. Nuhu Bammali Maternity Hospital, Kano 9. Kumbotsu Comprehensive Primary Health Centre, Kumbotsu, Kano. 10. Sharada Primary Health Centre, Kano | Approved | 23/04/2021 | GCP Inspections were conducted at three sites | Routine | Notice of Findings Sent to PI | |||||||
| 105 | Double Blind, Community-Based, Randomized Controlled Trial On The Use Of Ivermectin As Post Exposure Chemo-Prophylaxis For Covid-19 Among High Risk Individuals In Lagos"(IVERPEPCOV) | IVERPEPCOV | 3 | Prof Femi Babalola | Prof Femi Babalola | 23, Onitsha Crescent, Off Gimbiya Street, Garki Abuja | 02/10/2021 | drugs | review ongoing | NA | NA | NA | NA | Compliance Directive issued | |||
| 106 | A multi-country, multi-centre, three-arm, parallel group, double-blind, placebo-controlled, randomized trial of two doses of antenatal corticosteriods for women with a high probability of birth in the late preterm period in hospitals in low-resource countries to improve newborn outcome | ACTION-III Trial | Phase 3; | Prof Ebunoluwa Aderonke Adejuyigbe | Prof. Oluwafemi Kuti | Department of Obstetrics, Gynaecology and Perinatology, Obafemi Awolowo University, Ile Ife | 04/03/2022 | World Health Organization | Department of Reproductive Health and Research, Avenue Appia 20 1211 Geneva 27, Switzerland | 1. Obafemi Awolowo University Teaching Hospital Complex, Wesley Guild Hospital 2. University of Abuja Teaching Hospital 3. University of Benin Teaching Hospital 4. University of Medical Sciences Teaching Hospital, Ondo 6. Sacred Heart Hospital | Drug | Approved | 25/05/2022 | ongoing | conducted | routine | Notice of findings sent out to PI. |
| 107 | An adaptive, randomized, active-controlled, Open-label, Sequential Cohort, Multicenter Study to evaluate the efficacy, safety, tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in adults and pediatric participants with severe Plasmodium Falciparum Malaria (KARISMA-KAE609’S Role in Severe Malaria | KARISMA | 3 | Mr Adetukunmo Adekalu | Prof Olugbenga Mokuolu | Novartis Nig. Ltd. , Landmark Building , 3rd Floor 52-54 Isaac John Str. Ikeja, Lagos. | Novartis Nig. Ltd. , Landmark | Novartis Nig. Ltd. , Landmark Building , 3rd Floor 52-54 Isaac John Str. Ikeja, Lagos. | University of Ilorin Teaching Hospital, CEMTROD, Kwara | Intravenous Cipargamin | Approved | Completed | GCP Inspection conducted | Routine | Notice of Findings sent out to PI | ||
| 108 | Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 ( PROTECT-Surg) | PROTECT-Surg | Prof. Adesoji Ademuyiwa, | Department of Surgery, College of Medicine, Universityof Lagos | Under review | ||||||||||||
| 109 | Evaluation of the inhibitory activities of silymarin against SARS-CoV-2 | w | Dr Nathan Y. Shehu | Medicine Department, Jos University Teaching Hospital, Plateau State | Under review | ||||||||||||
| 110 | Traxenamic acid for the treatment of postpartum haemorrhage: An international, randomised, double blind placebo controlled trial | Prof Bukola Fawole | Not provided | London School of Hygiene & Tropical Medicine | 1. Adeoyo Maternity Hospital, Ibadan 2. Federal Medical Centre, Abeokuta 3. Federal Medical Centre, Azare 4. Federal Medical Centre, Gusau 5. Federal Medical Centre, Katsina 6. Federal Medical Centre, Makurdi 7. Federal Medical Centre, Owo 8. Irrua Specialist Teaching Hospital 9. Ladoke Akintola University of Technology Teaching Hospital, Osogbo 10. Ladoke Akintola University of Technology Teaching Hospital,Ogbomoso 11. Lagos State University Teaching Hospital 12. Lagos University Teaching Hospital 13. National Hospital, Abuja 14. Nnamdi Azikwe University Teaching Hospital 15. Obafemi Awolowo University Teaching Hospital 16. Obafem Awolowo University Teaching Hospital; Wesley Guild Hospital 17. Olabisi Onabanjo University Teaching Hospital 18. Seventh Day Adventist Hospital 19. University College Hospital, Ibadan 20. University of Abuja Teaching Hospital 21. University of Ilorin Teaching Hospital 22. University of Uyo Teaching Hospital 23. Delta State University Teaching Hospital 24. Federal Medical Centre, Birnin-Kebbi 25. Federal Medical Centre, Ido Ekiti 26. Federal Medical Centre, Owerri 27. Maitama District Hospital 28. Port Harcourt University Teaching Hospital 29. Kogi State Specialist Hospital 30. University of Calabar Teaching Hospital 31. University of Maiduguri Teaching Hospital 32. Ahmadu Bello University Teaching Hospital 33. Federal Medical Centre, Lokoja 34. Lagos Island Maternity Hospital 35. Mother & Child Hospital, Akure 36. Plateau State Specialist Hospital 37. Jos University Teaching Hospital 38. Lifegate Specialist Hospital 39. International Clinics & Hospital Ltd 40. IBB Specialist Hospital 41. Braithwaite Memorial Specialist Hospital 42. Federal Medical Centre, Bida 43. General Hospital, Minna 44. St Philomena Hospital, Benin City 45. Ekiti State University Teaching Hospital, Ado Ekiti 46. Gwarimpa General Hospital 47. Nyanya General Hospital 48. Aminu Kano Teaching Hospital 49. Federal Medical Centre, Umuahia 50. Federal Medical Centre, Yenegoa 51. Abubakar Tafawa Balewa University Teaching Hospital, Bauchi State 52. Ajeromi General Hospital, Ajegunle, Lagos State 53.Federal Medical Centre, Keffi, Nasarrawa State 54. Federal Teaching Hospital, Abakaliki, Ebonyi State 55. State Specialist Hospital, Akure, Ondo State 56. Federal Teaching Hospital, Gombe 57. University of Nigeria Teaching Hospital, Enugu 58. Usman Dan Fodio University Teaching Hospital 59. Karshi General Hospital | Approved | Not provided | GCP Inspections conducted at two sites | Routine | Notice of Findings Sent to PI | |||||||
| 111 | A Randomized Controlled Double-Blind Trial for Prevention of Recurrent Ischemic Priapism in Men with Sickle Cell Disease: A Pilot Study Priapism in Nigeria (PIN Study) | Bilya Sani Musa | Not provided | Not provided | Aminu Kano Teaching Hospital, Kano | Approved | 07/12/2021 | GCP Inspection not conducted | NA | NA | |||||||
| 112 | Simplied treatment for Eclampsia prevention using Magnesium sulphate; Aphase 3 randomized open label active control multinational multicenter non-inferiority study | Prof Hadiza S Galadanci | 12/01/2022 | Africa Centre of Excellence for Population Health and Policy | 1. Aminu Kano Teaching Hospital, Kano. Murtala Muhammad Specialist Hospital, Kano | Approved | 05/05/2022 | GCP Inspection scheduled | |||||||||
| 113 | Evaluation of the Safety and Efficacy of a Low-Cost Bubble CPAP-Device in patients with Respiratory Insufficiency from COVID-19 and other causes: A Phase-1 Clinical Trial | SHIVENT (CTA 99) | Phase 1 | SimileOluwa Onabanjo | Muyiwa Rotimi | Lagos State University Teaching Hospital, Ikeja, Lagos. | 20-Mar-22 | Shifa Technologies Limited | 26, Sockborn Close, Hamilton, Leichester LESINR, Leichestershire, United Kingdom | 1. Intensive Care Unit, Lagos University Teaching Hospital. | Medical Device | Approved | |||||
| 114 | A Multi study, multi center, three arm parallel double blind placebo control randomized trial of two doses of antenatal corticosteriod for women with high probablilty of birth in the late preterm perod with hospitals of low resource countries to improve low birth outcomes. ACTION 3 (UCH) | Dr Adejumoke Ayede | 10/03/2022 | WHO | University College Hospital, Ibadan | Approved | 26/04/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 115 | A Randomized, Double-Blind, Placebo Controlled Phase I Study to assess the safety and efficacy of P564X (Combination of Tadalafil, Silodosin and Paroxetine HCI CR) for Premature Ejaculation (PE) | Dr Olugbenga Owoeye | 28/05/2022 | Zyvran Pharmaceutical Inc | federal neuropsychiatric hospital yaba | Compliance directive was issued | Not provided | Not provided | NA | NA | |||||||
| 116 | Aphase 3 multicenter randomized double blind placebo controlled trial to evaluate efficacy of voxelotor for treatment of leg ulcer in patient with sickle cell disease. ((RESOLVE STUDY). GBT 440-042. | GBT 440-042 (RESOLVE STUDY) | Xcene Research Ltd | 22/07/2022 | Global Blood Therapeutics | 1. Barrau Dikko Teaching Hospital, Kaduna 2. Lagos University Teaching Hospital, Lagos 3. University of Nigeria Teaching Hospital, Enugu 4. Aminu Kano Teaching Hospital, Kano 5. University of Abuja Tecahing Hospital, Abuja. 6. University of Calabar Teaching Hospital, Calabar. | Approved | 21/09/2022 | GCP Inspection conducted on some sites | Routine | Notice of Findings Sent to PI | ||||||
| 117 | An Open-label extension study to evaluate the long-term safety of Inclacumab administered to participants with sickle cell disease who have participated in an Inclucumab clinical trial (GBT2104-133) | Xcene Research Ltd | 20/04/2022 | Global Blood Therapeutics | Lagos University Teaching Hospital, Lagos 2. National Hospital, Abuja 3. University of Nigeria Teaching Hospital 4. Aminu Kano Teaching Hospital, Kano 5. University of Abuja Teaching Hospital, Gwalgwalada, Abuja 6. University of Calabar Teaching Hospital, Calabar | Approved | 29/07/2022 | GCP Inspection conducted on three sites | Routine | Notice of Findings Sent to PI | |||||||
| 118 | An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial (GBT 2104-133) | GBT 2104-133 | 3 | Excene Research | Dr Martin Mmeremikwu | 15 Ogundana Street, Off Allen Avenue, Ikeja Lagos, Nigeria | 30/03/2022 | GBT/Pfizer Specialist | University Of Minnesota, Minneapolis, MN 55455, United States | 1.Department of Pediatrics, Aminu Kano Teaching Hospital, Kano. 2. Department of Medicine, Lagos University Teaching Hospital, Surulere, Lagos 3. Department of Hematology, University of Abuja Teaching Hospital. 4. Department of Hematology, University of Nigeria Teaching Hospital, Enugu 5. Department of Hematology, National Hospital, Abuja 6. Department of Pediatrics, College of Medical Sciences, University of Calabar, Nigeria 7. Barau Dikko Hospital, Kaduna 8. Ahmadu Bello University Teaching Hospital, Zaria, Kaduna. | Drug | approved | 29/07/2022 | ongoing | Conducted on | Routine inspection/ 14/03/2024 | Met minimum regulatory requirements |
| 119 | A phase 2/3, Double blind, randomised, placebo-controlled, mulitcenter study to evaluate the efficacy and safet of mitapivat in subjects with sickle cell disese | Angios Pharmaceuticals Inc. 88 Sidney Street, Cambridge, MA, 02139-4169, USA | Jul-22 | Angios Pharmaceuticals Inc | 1. Universty of Abuja Teaching Hospital, Gwagwalada, Area Council, Abuja UNIVERSTY OF CALABAR TEACHING HOSPITAL. UNIVERSITY OF NIGERIA TEACHING HOSPITAL LAGOS UNIVERSITY TEACHING HOSPITAL National Hospital Abuja, 265 Independence Avenue, CBD, Abuja. BARAU DIKKO TEACHING HOSPITAL | APPROVED | 22/08/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 120 | Intravenous Ferric carboxy maltose versus oral sulphate for tretament of post partum anemia in Nigerian women- An open label randomized control trial (IVON PP) | Professor Bosede B. Afolabi, | 29/08/2022 | Bill & Melinda Gate Foundation | i. Lagos University Teaching Hospital (LUTH), Idi-Araba, Lagos ii. Mother and Child Centre, Amuwo-Odofin iii. Mother and Child Centre, Gbaja (maternity unit of Randle General Hospital, Surulere), Lagos iv. General Hospital, Ifako Ijaiye v. Ipaja Primary Health Centre, Alimosho L.G.A., Lagos i. University of Port Harcourt Teaching Hospital (UPTH), PortHarcourt ii. Okrika General Hospital, Okrika iii. Bori General Hospital, Bori iv. Ahoada General Hospital, Ahoada v. Model Primary Health Care Centre, Orogbum i. Aminu Kano Teaching Hospital (AKTH), Kano ii. Waziri Gidado GH iii. Nuhu Bammali GH iv. Sheik Jeddah GH v. Kabuga PHC i. University of Ilorin Teaching Hospital (UITH), Ilorin, Kwara ii. General hospital Ilorin iii. Civil Service Hospital, Ilorin iv. Adewole basic health center v. Okelele Health Centre | APPROVED | 18/09/2022 | GCP Inspection conducted on 2nd and 3 rd April, 2025. | Routine | Notice of Inspection Findings sent to PI | |||||||
| 121 | A Phase 2/3 double-blind Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects with Sickle Cell Disease (MITAPIVAT STUDY | MITAPIVAT | Phase 2/3 | Prof. Obiageli Nnodu, | Prof. Obiageli Nnodu, | University of Abuja Teaching Hospital, Gwagwalada. | Jul-22 | Agios Pharmaceuticals, | Agios Pharmaceuticals, NC.Cambridge, MA,States Of America (USA). | University of Abuja Teaching Hospital, Gwagwalada. | Routine Inspection | Approved | 22/08/2022 | Ongoing | GCP Inspection conducted on 19th - 20th March 2025 | Routine Inspection | Notice of Inspection findings sent to PI |
| 122 | Fractional doses/COVID 19 vaccine trial; Safety and immunogenicity of fractional doses of Biotech, oxford, Astazeneca & Janssen COVID-19 vaccine among Nigeria adult- A randomized non-inferiority triple blinded trial. | Prof. Henry Omorogie Egharevba | 14/07/2022 | Federal Ministry of Health | Nigerian Institute of Medical Research (NIMR) Nnamdi Azikiwe University Teaching Hospital (NAUTH) Delta State University Teaching Hospital (DELSUTH) Aminu Kano Teaching Hospital, Kano.National Pharmaceutical Research and Development (NIPRD) | approved | 01/10/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 123 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients with Sickle Cell (GBT 440-042) | GBT 440-042 | 3 | Excene Research | Dr Halima Bello Manga | Lafia Road City Center, Kaduna, Nigeria | 20/07/2022 | GBT/Pfizer Specialist | University Of Minnesota, Minneapolis, MN 55455, United States | 1.Department of Pediatrics, Aminu Kano Teaching Hospital, Kano. 2. Department of Medicine, Lagos University Teaching Hospital, Surulere, Lagos 3. Department of Hematology, University of Abuja Teaching Hospital. 4. Department of Hematology, University of Nigeria Teaching Hospital, Enugu 5. Department of Hematology, National Hospital, Abuja 6. Department of Pediatrics, College of Medical Sciences, University of Calabar, Nigeria 7. Barau Dikko Hospital, Kaduna 8. Ahmadu Bello University Teaching Hospital, Zaria, Kaduna.. | Drug | Approved | 21/09/2022 | ongoing | Conducted | Triggered inspection/15/01/2024 | Notice of findings sent out to PI |
| 124 | A phase 2/3 randomized, multicentre study of GBT 021601 administered orally to participants with sickle cells diseases and open label pharmacokinetics study in paediatric population with sickle cell disease. | Xcene Research Ltd | 01/03/2022 | Global Blood Therapeutics | Lagos University Teaching Hospital (LUTH) 2. University | approved | 03/06/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 125 | An Open-Label Extension Study to Evaluate the Long-term Safety of GBT021601 Administered to Participants with Sickle Cell Disease Who Have Participated in a GBT021601 Clinical Trial | Xcene Research Ltd | 19/12/2022 | Global Blood Therapeutics | Lagos University Teaching Hospital (LUTH) 2. University College Hospital (UCH) 3. Aminu Kano Teaching Hospital | approved | 11/05/2023 | GCP Inspection not conducted | NA | NA | |||||||
| 126 | A Randomized, Double-Blind, Placebo Controlled Phase I Study to assess the safety and efficacy of P564X (Combination of Tadalafil, Silodosin and Paroxetine HCI CR) for Premature Ejaculation (PE | RCT for safety and efficacy of P564X for premature ejaculation(CTA 184) | Phase 1 | nkechi Nwaogu | Owoeye olugbenga | 13, Adeleke Odunuga Street, Harmony Estate, Ogba Ifako-ijaye, Lagos, Nigeria | 01-Dec-22 | Zyvran Pharmaceutical Inc | 13, Adeleke Odunuga Street, Harmony Estate, Ogba Ifako-ijaye, Lagos, Nigeria | 1. federal neuropsychiatric hospital yaba | Drug | ||||||
| 127 | A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients with Sickle Cell Disease who are at Increased Risk for Primary Stroke with Protocol Version 1.0 | Elizabeth Miron | 10/11/2022 | IQVIA | Lagos University Teaching Hospital, Lagos 2. University College Hospital, Ibadan 3. Aminu Kano Teaching Hospital, Kano | Approved | 22/05/2023 | GCP Inspection Not conducted | |||||||||
| 128 | comparison of intracuff alkalinized ropivacaine, alkalinized lidocaine and air on the response to endotracheal tube during emergence from elective otorhinolaryngological surgeries. | Dr. EVBOMEMEN JOY OBHAJAJEMEN | 29/07/2022 | Dr. EVBOMEMEN JOY OBHAJAJEMEN | University College Hospital (UCH), Ibadan | approved | 03/11/2022 | GCP Inspection not conducted | NA | NA | |||||||
| 129 | Evaluation of the Safety and Efficacy of a Low-Cost Bubble CPAP-Device in patients with Respiratory Insufficiency from COVID-19 and other causes: A Phase-1 Clinical Trial | SHIVENT (CTA 99) | Phase 1 | SimileOluwa Onabanjo | Muyiwa Rotimi | Lagos State University Teaching Hospital, Ikeja, Lagos. | 20-Mar-22 | Shifa Technologies Limited | 26, Sockborn Close, Hamilton, Leichester LESINR, Leichestershire, United Kingdom | 1. Intensive Care Unit, Lagos University Teaching Hospital. | Medical Device | Approved | |||||
| 130 | Efficacy and safety of GMRx2 (a single pill combination containing Telmisartan/amlodipine/indapamide) compared to placebo for the treatment of hypertension: An international, multi center, randomized, double-blind, placebo-controlled, parallel group trial | George Medicines Pty Limited | 02/02/2023 | George Medicines Pty Limited | Univesrity of Abuja Teaching Hospital, Abuja | Under Review | 26/04/2023 | GCP Inspection not conducted | NA | NA | |||||||
| 131 | Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial | Professor Oladapo Olayemi | 01/08/2023 | London School of Hygiene and Tropical Medicine (LSHTM) | Department of O&G, University College Hospital, Ibadan, Oyo | Approved | 13/12/2023 | GCP Inspection not conducted | NA | NA | |||||||
| 132 | Primary Prevention of Stroke in Children with SCD in Sub-Saharan Africa II: A Multicenter, Open-label, Single-arm Type I Hybrid Clinical Trial | Bilya Sani Musa | 06/11/2023 | Vanderbilt University Medical Centre | Aminu Kano Teaching Hospital, Kano 2. Murtala Muhammed Specialist Hospital, Kano | Under review | Not provided | Not provided | |||||||||
| 133 | A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatmentA randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment | Novartis | 27/10/2023 | NOVARTIS Pharma AG | Centre for Malaria and Other Tropical Diseases Care | Compliance Directive was issued | |||||||||||
| 134 | A Phase Iii, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab And Bevacizumab, With Or Without Tiragolumab, In Patients With Untreated Locally Advanced Or Metastatic Hepatocellular Carcinoma | Terver Akindigh | 22/11/2023 | F. Hoffmann-La Roche Ltd. | Jos University Teaching Hospital, Jos 2. Lagos University Teaching Hospital | COMPLIANCE DIRECTIVE WAS ISSUED | |||||||||||
| 135 | A RANDOMIZED, MULTI-CENTRIC, OPEN-LABEL, PARALLEL, ACTIVE-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF ARTEROLANE MALEATE–PIPERAQUINE PHOSPHATE TABLETS IN COMPARISON TO ARTEMETHER–LUMEFANTRINE TABLETS FOR THE TREATMENT OF UNCOMPLICATED FALCIPARUM MALARIA IN ADOLESCENT AND ADULT NIGERIAN PATIENTS | SYNRIAM | Phase IV, | Prof Olufunsho Awodele | Prof Olufunsho Awodele | Department of Pharmacology ,College of Medicine ,LUTH ,Lagos | 29th May 2023 | Sun Pharmaceutical Industries | Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (East) Mumbai Mumbai City MH IN 400063. | Lagos University Teaching Hospital | Artemether-Lumefantrine | Approved | 4th August 2023 | Ongoing | GCP Inspection conducted on 10th and 11th March ,2025 | Routine of Inspection | Notice of Inspection findings sent to PI |
| 136 | A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSVΔG-LASV-GPC Vaccine in Adults and Children Residing in West Africa | Lassa fever study | 2 | Samirah Sani Mohammed | Dr Bolaji Tiyaminu | CRC, Abuja | 05/09/2023 | US ARMY- WRAIAR | 1. Clinical Research Centre (CRC), Abuja | APPROVED | 18/01/20224 | GCP Inspection not conducted GCP inspection Conducted on 12th- 13th March 2025 | Routine Inspection | Notice of Inspection Findings sent to PI | |||
| 137 | “Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to placebo for the treatment of hypertension: An international, multi-center, randomized, double-blind, placebo controlled, parallel-group trial (GMRx2-HTN-2020-PCT1)” VERONICA EXTENSION | VERONICA EXTENSION | 3 | Dr Dike Ojji | Dr Dike Ojji | University of Abuja Teaching Hospital, Gwagwalada | 16/03/2023 | The Geaorge Institute for Global Health. | Level 5, 1 king Street Newton, Sydney, NSW 2042, Australia | Isoloation | Drug | Approved | 23/03/2023 | completed | Conducted | Routine inspection/ 21/02/2024 | Notice of Findings sent to PI |
| 138 | Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE)” | STRIVE | Phase 2 | Dr Nnakelu Eriobu | Dr Nnakelu Eriobu | University of Abuja Teaching Hospital, Abuja | 15/01/2023 | National Institute of Allergy and Infectious Disease (NIAID) | National Institute of Allergy and Infectious Disease (NIAID),Maryland United States of America | University of Abuja Teaching Hospital, Abuja | S-217622 Shionogi Protease Inhibitor of SARS-CoV-2 3CLpro | approved | 13/09/2023 | Ongoing | GCP Inspection conducted on 15th and 16th May 2025 | Routine Inspection | Notice of Findings Sent to PI |
| 139 | A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment Sponsor: Novartis Pharma AG, Lichtstrasse 35, 4056 Basel, Switzerland | Norvartis | 27/10/2023 | Novartis Nigeria | Centre for Malaria and Other Tropical Diseases | Under Review | |||||||||||
| 140 | REDUCING MORTALITY IN ADULTS WITH ADVANCED HIV DISEASE | Dr Kemi Adekambi | 01/02/2023 | PUBLIC HEALTJ RESEARCH INSTITUTE, CANADA | UNIVERSITY COLLEGE HOSPITAL, IBADAN. 2. JOS UNIVERSITY TEACHING HOSPITAL 3. USMAN DANFODIYO UNIVERSITY TEACHING HOSPITAL 4. NIGER DELTA UNIVERSITY TECHING HOSPITAL 5. UNIVERSITY OF ABUJA TEACHING HOSPITAL 6. LAGOS UNIVERSITY TEACHING HOSPITAL 7.UNIVERSITY OF NIGERIA TEACHING HOSPITAL, ENUGU. 8. UNIVERSITY OF UYO TEACHING HOSPITAL, UYO 9. UNIVERSITY OF CALABAR TEACHING HOSPITAL, CALABAR 10. FEDERAL MEDICAL CENTRE UMUAHIA 11. AMINU KANO TEACHING HOSPITAL, KANO | Approved | 28/09/2023 | GCP inspection not conducted | |||||||||
| 141 | A RANDOMIZED, MULTI-CENTRIC, OPEN-LABEL, PARALLEL, ACTIVE CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF ARTEROLANE MALEATE–PIPERAQUINE PHOSPHATE TABLETS IN COMPARISON TO ARTEMETHER–LUMEFANTRINE TABLETS FOR THE TREATMENT OF UNCOMPLICATED FALCIPARUM MALARIA IN ADOLESCENT AND ADULT NIGERIAN PATIENTS | SYNRIAM | Olufunsho Awodele | 29/05/2023 | RANBAXY NIGERIA LIMITED | Lagos University Teaching Hospital, Lagos 2. Obafemi Awolowo University Teaching Hospital, Ile-Ife | Approved | 04/08/2023 | GCP Inspection not conducted | ||||||||
| 142 | Safety and tolerability of adjunct dexamethasone in addition to standard of care antiviral therapy compared to standard of care antiviral therapy alone for the treatment of moderate to severe Lassa Fever: An open label randomized controlled phase II clinical trial | LADEX | Phase 2 | Sylvanus Okogbenin | Prof Sylvanus Okogbehin | University of Nigeria Teaching Hospital Ituku-Ozalla, Enugu-Port Harcourt Expressway, P.M.B. 01129, Enugu, Nigeria. | 18/12/2023 | Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany. | IAVI,Broad Street, 9th Floor, New York, NY 10004, United States | Irrua Specialist Teaching Hospital (ISTH) | Dexamethasone phosphate 4mg/1mL | approved | 13/02/2024 | Ongoing | GCP Inspection not conducted on 8th and 9th May 2025 | Routine Inspection | Notice of Findings Sent to PI |
| 143 | Feasibility and Acceptability of use of Innovative Cancer Medicines in a Limited Resource Setting at National Hospital Abuja, in Nigeria | Paulette Ibeka | 30/11/2023 | Parker Institute for Cancer Immunotherapy | National Hospital Abuja | Payment has not been made | |||||||||||
| 144 | Diagnostic and triaging accuracy of nurses with and without MedBrain® for paediatric patients in Enugu, Nigeria: a double-blind randomised control trial | Eng Paul Dinwoke | 29/11/2023 | Molcom Multi-Concepts Limited Nigeria/ Medbrain Spain | ESUT Teaching Hospital, Parklane Enugu | COMPLIANCE DIRECTIVE WAS ISSUED | |||||||||||
| 145 | Dolutegravir and Darunavir Evaluation in adults Failing Therapy. A Phase IIIB/IV Randomized Open-label Trial Comparing Dolutegravir with Pharmaco-enhanced Darunavir Versus Dolutegravir with predetermined Nucleosides Versus Recommended Standard of Care ART Regimens in Patients with HIV-1 Infection Failing First Line Therapy. | Dr Vivian Kwaghe | University of Abuja Teaching Hospital, Gwagwalada Area Council, Abuja. | Routine inspection/ 07-12-2020 | Notice of Findings Sent to PI | ||||||||||||
| 146 | The Efficacy and Safety of IHP (Intercedd Health Products] Detox Tea - A Special Blend of Andrographis paniculata; Garcinia kola and Psidiumguajava L. (Myrtaceae) for the Treatment of Coronavirus Disease 2019 [COVID-19]: A Study Pilot for a Randomized Clinical Trial (IHP- Detox Tea Study (IHP DETOX TEA) | Dr Edomisan Olusoji Temiye | Lagos University Teaching Hospital, Lagos | Routine inspection/ 06-04-2022 | Notice of Findings Sent to PI | ||||||||||||
| 147 | Zinc Acceptability in children with acute diarrhoea presenting at children emergency clinic of the paediatric department in selected hospitals in Lagos state (ZINC PALATABLILITY STUDY) | (ZINC PALATABLILITY STUDY) | Dr Edem Duke | Alimosho General Hospital, Igando, Lagos State | Routine inspection/ 25-05-2022 | Notice of Findings Sent to PI | |||||||||||
| 148 | Zinc Acceptability in children with acute diarrhoea presenting at children emergency clinic of the paediatric department in selected hospitals in Lagos state (ZINC PALATABLILITY STUDY) | (ZINC PALATABLILITY STUDY) | Dr Oyejoke Oyapero | Maternal and Child Center, Amuwo Odofin, Lagos. | Routine inspection/ 01-06-2022 | Met minimum requirements | |||||||||||
| 149 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to evaluate the efficacy of Voxelotor (GBT440) for the treatment of Leg Ulcers in Patients with Sickle cell Disease (GBT 440-042) | GBT 440-042 | Dr Adeseye Michael Akinsete | Lagos University Teaching Hospital, Lagos | Routine inspection/ 16-01-2023 | Notice of Findings Sent to PI | |||||||||||
| 150 | PErioperative respiratory care and outcomes for patieNts Undergoing hIgh risk abdomiNal surgery. A 2x2 factorial, international pragmatic randomised controlled trial across low and middle-income countries. (PENGUIN) | (PENGUIN) | Prof Adesoji Ademuyiwa | Lagos University Teaching Hospital, Lagos | Routine inspection/ 31-01-2023 | Notice of Findings Sent to PI | |||||||||||
| 151 | Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19” (PROTECT SURG Study) | (PROTECT SURG Study) | Prof Adesoji Ademuyiwa | Lagos University Teaching Hospital, Lagos | Routine inspection/ 01-02-2023 | Notice of Findings Sent to PI | |||||||||||
| 152 | A Randomized, Double-blind, Placebo-controlled, Multicentre Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso occlusive Crises (GBT2104-131) | (GBT2104-131) | Dr Adeseye Michael Akinsete | Lagos University Teaching Hospital, Lagos | Routine inspection/ 12-01-2023 | Notice of Findings Sent to PI | |||||||||||
| 153 | A multi-country, multi-centre, three-arm, parallel group, double-blind, placebo controlled, randomized trial of two doses of antenatal corticosteroids for women with high probability of both in late preterm period in hospitals in low-resource countries to improve new born outcome (ACTION III) | (ACTION III) | Dr Dedeke Olabisi | Sacred Hospital, Abeokuta | Routine inspection/ 05-01-2023 | Notice of Findings Sent to PI | |||||||||||
| 154 | Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of postpartum anemia in Nigerian women, an open labeled randomized controlled trial and implementation study (IVON-PP) | Dr Aderolu Monsurat Bolanle | Mother & Child, Gbaja, Lagos | Routine inspection/ 16-01-2023 | Notice of Findings Sent to PI | ||||||||||||
| 155 | Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of postpartum anemia in Nigerian women, an open labeled randomized controlled trial and implementation study (IVON-PP) | Dr Omolayole Abayomi | Ipaja Primary Health Center, Alimosho, Lagos | Routine inspection/ 23-01-2023 | Notice of Findings Sent to PI | ||||||||||||
| 156 | Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of postpartum anemia in Nigerian women, an open labeled randomized controlled trial and implementation study (IVON-PP) | General Hospital Ifako Ijaiye, Lagos | General Hospital Ifako Ijaiye, Lagos | Routine inspection/ 12-01-2023 | Notice of Findings Sent to PI | ||||||||||||
| 157 | Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of postpartum anemia in Nigerian women, an open labeled randomized controlled trial and implementation study (IVON-PP) | Dr Adaramoye Victoria Olawunmi | Lagos University Teaching Hospital, Lagos | Routine inspection/30-01-23 | Notice of Findings Sent to PI | ||||||||||||
| 158 | Intravenous Versus Oral iron for iron deficiency anemia in pregnant Nigerian women IVON | Dr. Femi Omololu | Lagos Island Maternity Centre, Lagos | Routine inspection/ 02-02-2023 | Notice of Findings Sent to PI | ||||||||||||
| 159 | Intravenous Versus Oral iron for iron deficiency anemia in pregnant Nigerian women IVON | Dr Opeyemi Akinajo | Simpson Primary Health Centre, Ebute-Metta, Lagos | Routine inspection/25-01-23 | Notice of Findings Sent to PI | ||||||||||||
| 160 | Intravenous Versus Oral iron for iron deficiency anemia in pregnant Nigerian women IVON | Dr Mercy Alokha | Mother and Child centre, Amuwo-odofin, Lagos. | Routine inspection/19-01-23 | Notice of Findings Sent to PI | ||||||||||||
| 161 | Safety & Immunogenicity of Fractional doses of Moderna-mrna1273, Oxford/Astrazeneca, and Janssen Covid-19 Vaccines among Nigerian Adults- a randomized non-Inferiority double blind trial (SIFCoVAN) | SIFCOVAN | 2 | Nigerian Institute of Medical Research, Yaba, Lagos | Prof. Oliver Ezechi | Department of Clinical Sciences, Centre for Reproductive and Population Health Studies. | FMOH, Nigeria | Abuja, Nigeria | Nigerian Institutes of Medical Research, NIMR Delta state University Teaching Hospital Nnamdi Azikiwe University Teaching Hospital Aminu Kanu Teaching Hospital, Kano National Pharmaceutical Research and Development (NIPRID) | Vaccine | Approved | 29/09/2022 | completed | conducted | Routine inspection/12-09-2023 | Notice of Findings Sent to PI | |
| 162 | A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Readmission in Participants with Sickle Cell Disease and Recurrent Vaso Occlusive Crises GBT 2104-132 | GBT 2104-132 | 3 | Excene Research | Dr Shehu Abdullahi | 15 Ogundana Street, Off Allen Avenue, Ikeja Lagos, Nigeria | GBT/Pfizer Specialist | University Of Minnesota, Minneapolis, MN 55455, United States | 1.Department of Pediatrics, Aminu Kano Teaching Hospital, Kano. 2. Department of Medicine, Lagos University Teaching Hospital, Surulere, Lagos 3. Department of Hematology, University of Abuja Teaching Hospital. 4. Department of Hematology, University of Nigeria Teaching Hospital, Enugu 5. Department of Hematology, National Hospital, Abuja 6. Department of Pediatrics, College of Medical Sciences, University of Calabar, Nigeria 7. Barau Dikko Hospital, Kaduna 8. Ahmadu Bello University Teaching Hospital, Zaria, Kaduna. | Drug | Approved | 23/12/2021 | ongoing | conducted | Routine inspection/ 12/03/2024 | Notice of Findings sent to PI | |
| 163 | A Phase 3 Randomized, Double Bind, Placebo-Controlled study of Voxelotor in Pediatric Patients with Sickle Cell Disease GBT 440-032 | GBT440-032 | 3 | Excene Research | Dr Akinseye M. Akinste | 15 Ogundana Street, Off Allen Avenue, Ikeja Lagos, Nigeria | Global Blood Therapeutics (GBT), Inc | 16/05/2020 | 1.Department of Pediatrics, Aminu Kano Teaching Hospital, Kano. 2. Department of Medicine, Lagos University Teaching Hospital, Surulere, Lagos 3. Department of Hematology, University of Abuja Teaching Hospital. 4. Department of Hematology, University of Nigeria Teaching Hospital, Enugu 5. Department of Hematology, National Hospital, Abuja 6. Department of Pediatrics, College of Medical Sciences, University of Calabar, Nigeria 7. Barau Dikko Hospital, Kaduna 8. Ahmadu Bello University Teaching Hospital, Zaria, Kaduna. | Drug | Approved | 20/07/2020 | ongoing | conducted | Routine inspection/ May-24 | Met minimum regulatory requirements |
