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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00621855 |
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered b.i.d, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.
Condition | Intervention | Phase |
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Coronary Disease |
Drug: Dabigatran etexilate Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-Centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM) |
Estimated Enrollment: | 2206 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | September 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:
Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1160.67, RE-DEEM EUDRACT2007-004301-99 |
Study First Received: | February 13, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00621855 |
Health Authority: | Belgium: Federal Agency for Medicines and Health Products; Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; Canada: Health Canada, Therapeutic Products Directorate; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Denmark: The Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Georgia: State Regulation Agency of Medical Activity, GE-0160 Tbilisi; Germany: BfArM-Federal Authorities for Drugs and Medical Devices; Great Britain: MHRA; Hungary: National Institute of Pharmacy, H-1051 Budapest; India: Drug Control General of India; Ireland: Irish Medicines Board; Italy: Comitato Etico Unico per la Provincia di Parma - Azienda Ospedaliera di Parma; Korea, Republic of: KOREA Food and Drug Administration (KFDA); Netherlands: Central Committee on Research Involving Human Subjects (CCMO); Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych; Romania: National Medicines Agency, Bucharest; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Spain: Agencia Española de Medicamentos y Productos Santarios; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Arterial Occlusive Diseases Coronary Disease Signs and Symptoms Heart Diseases Aspirin Clopidogrel |
Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |