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| Study 12 of 19 for search of: | dabigatran etexilate |
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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00262600 |
Purpose
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 etex 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) |
| Enrollment: | 18115 |
| Study Start Date: | November 2005 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)
Exclusion Criteria:
Contacts and Locations
Show 952 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1160.26, 2005-003894-26 |
| Study First Received: | December 6, 2005 |
| Last Updated: | January 14, 2010 |
| ClinicalTrials.gov Identifier: | NCT00262600 History of Changes |
| 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; Canada: Health Canada; 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; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: AFFSAPS; Germany: Federal Institute for Drugs and Medical Devices; 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; Israel: Ministry of Health; 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; Mexico: Federal Commission for Sanitary Risks Protection; 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; Sweden: Medical Products Agency; 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 |
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Anticoagulants Heart Diseases Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Warfarin Brain Diseases |
Cerebrovascular Disorders Pharmacologic Actions Pathologic Processes Therapeutic Uses Brain Ischemia Cardiovascular Diseases Atrial Fibrillation Brain Infarction Arrhythmias, Cardiac |