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** Agency implements ICH Q1 and Q7 Guidelines **** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
Title of Study: 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 v
Subtitle: WHO Carbetocin RTS Study
Protocol; Version: A65870; 1.1
Phase of Study: Phase 3;
Study Type: grant aided study
Approval Date:
Applicant Name: Dr Bukola Fawole
Address: Department of Obsterics & Gynaecology , University College Hospital, Ibadan
Date of Application: 2015-02-03
Applicant Name: Dr Bukola Fawole
Sponsor: Department of Reproductive Health & Research, World Health Organization
Address of Sponsor: Avenue Appia 20 1211 Geneva 27 switzerland
Trial Sites: 1. Department of Obstetrics & Gynaecology, University College Hospital, Ibadan.
Product Type: Drug
Status of Approval: Completed
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1
3
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
ECTS/17/001/EC10018
Version 02
Phase 3;
industry sponsor
Xcene Research Ltd
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)
Medical Device
Approved
26/09/2019
Recruiting
2
4
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
Triple therapy prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT)
ISRCTN76912190
Version 3
Phase 3;
grant aided study
Xcene Research Ltd
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), I
Drug
Approved
26/09/2019
Recruiting
3
5
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
Ultrasound Study
RV 466 UKT/WRIAR No. 2638, Version 1.4
Not Applicable
Phase 3;
industry sponsor
U.S Military HIV Research Program Walter Reed Army Institute of Research, Embassy of the United States of Amirica, Abuja, Nigeria
Defense Advanced Research Projects Agency (DARPA), No.7, Clinical Research Center, Usuma Street, Maitama, ABuja.
29/10/2019
Defence Advance Research Projects Agency (DARPA), Walter Reed Army Institute of Research
No. 7c, Clinical Research Center, Usuma Street, Maitama, Abuja.
1. 68, Nigerian Army Reference Hospital, Lagos
2. General Hospital, Ikorodu, Lagos
Medical Device
Approved
02/01/2020
Recruiting
4
6
Stroke Prevention In Young Adults with Sickle Cell Anaemia
SPIYA
Phase 3;
grant aided study
Aminu Kano Teaching Hospital
2, Zaria Road, Kano
24/04/2019
National Institute of Health
1. Aminu Kano Teaching Hospital
Drug
Approved
31/12/2019
on-going
5
7
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
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
On-going
6
8
Assessing Response to neo-adjuvant Taxotere and Trastuzumab in Nigerian women with HER2-positive breast cancer
ARTETTA
CABC123D4567
1
Phase 3;
industry sponsor
Prof. (Mrs) Peace Babalola
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
7
9
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 v
WHO Carbetocin RTS Study
A65870
1.1
Phase 3;
grant aided study
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
8
10
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
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 out
ACTION-1 Trial
A65913
1.10
Phase 3;
grant aided study
Dr Idowu Ayede
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
Biologics
Approved
09/01/2018
On-going
10
12
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 out
ACTION II Trial
A65916
1.5
Phase 3;
grant aided study
Dr Adejumoke Idowu Ayede
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 H
