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Sponsors and Collaborators: |
Bristol-Myers Squibb Pfizer |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00643201 |
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
Condition | Intervention | Phase |
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Venous Thrombosis |
Drug: Enoxaparin Drug: warfarin Drug: Placebo for apixaban Drug: Placebo for enoxaparin Drug: Placebo for warfarin Drug: apixaban |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism |
Estimated Enrollment: | 2900 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until INR ≥2, twice daily
Drug: warfarin
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Drug: Placebo for apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
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2: Experimental |
Drug: Placebo for enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2, twice daily
Drug: Placebo for warfarin
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
Drug: apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CV185-056, EUDRACT: 2007-007867-25 |
Study First Received: | March 20, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00643201 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Mexico: Federal Commission for Sanitary Risks Protection; Austria: Secretariat of Health; Denmark: Danish Medicines Agency; France: Ministry of Health; Germany: Ministry of Health; Israel: Ministry of Health; Italy: Ministry of Health; Norway: Directorate for Health and Social Affairs; Spain: Spanish Agency of Medicines; South Africa: Department of Health; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: Ministry of Health; Hungary: Ministry of Health, Social and Family Affairs; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Australia: Department of Health and Ageing Therapeutic Goods Administration; Hong Kong: Department of Health; India: Central Drugs Standard Control Organization; Korea: Food and Drug Administration; Malaysia: National Pharmaceutical Control Bureau; Taiwan: Department of Health; Romania: National Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Singapore: Ministry of Health; China: State Food and Drug Administration |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases |
Vascular Diseases Venous Thrombosis Warfarin Thrombosis Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |