Powered by ZigaForm version 3.9.8.8

Application for Clinical Trials

Product Details

Title of Study: 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

Subtitle: ACTION-1 Trial

Protocol; Version: A65913; 1.10

Phase of Study: Phase 3;

Study Type: grant aided study

Approval Date:

Applicant Name: Dr Idowu Ayede

Address: Department of Obstetrics & Gynecology, University College Hospital, Ibadan

Date of Application: 2017-09-06

Applicant Name: Dr Idowu Ayede

Sponsor: World Health Organization

Address of Sponsor: Department of Reproductive Health and Research, Avenue Appia 20 12111 Geneva 27, Switzerland

Trial Sites: 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

Product Type: Biologics

Status of Approval: On-going


wdt_ID ID Title of Study Short Title Protocol Number Version Number Phase of Study Study Type Name of Applicant Address of Applicant Application Date Name of Sponsor Address of Sponsor Trial Site(s) Product Type Status of Clinical Trial Application Trial Authorisation Date Status of Approved Trial(s) Details
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 NCT03017872 Version 2.0 Phase 3; grant aided study The Institute of Human Virology-IHVN 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 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 SPRING TRIAL May 23, 2016 Phase 3; grant aided tudy 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
9 11 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 Drug Approved 09/01/2018