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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00262600 |
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation Cerebrovascular Accident |
Drug: Dabigatran etexilate Drug: Warfarin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: Prospective, Multi-Centre, Parallel-Group, Non-Inferiority Trial (RE-LY Study) |
Estimated Enrollment: | 18000 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1160.26, 2005-003894-26 |
Study First Received: | December 6, 2005 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00262600 |
Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica); Australia: Responsilble Ethics Committee; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicines and Health Products; Brazil: National Health Surveillance Agency; Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; China: State Food and Drug Administration; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Finland: National Agency for Medicines; France: AFFSAPS; Great Britain: MHRA; Greece: National Organization for Medicines (EOF) National Ethics Committee; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy, H-1051 Budapest; India: Drug Control General of India; Italy: Comitato Etico Indipendente - BOLOGNA; Japan: Ministry of Health, Labor and Welfare; Korea, Republic of: KOREA Food and Drug Administration (KFDA); Malaysia: Drug Control Authority; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Philippines: Bureau of Food and Drug; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: INFARMED - National Authority of Medicines and Health Products, IP; Romania: National Medicines Agency, Bucharest; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Health Sciences Authority; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; South Africa: MCC; Spain: Agencia Española del Medicamento y Productos Sanitarios; Switzerland: Swissmedic; Taiwan: Department of Health, Executive Yuan, Taiwan; Thailand: Thai Food & Drug Administration; Turkey: Ministry of Health Central Ethics Committee; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Heart Diseases Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Warfarin Ischemia Brain Diseases |
Cerebrovascular Disorders Embolism Brain Ischemia Atrial Fibrillation Brain Infarction Infarction Arrhythmias, Cardiac |
Anticoagulants Pathologic Processes Therapeutic Uses Hematologic Agents |
Nervous System Diseases Cardiovascular Diseases Pharmacologic Actions |