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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00313300 |
The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
Condition | Intervention | Phase |
---|---|---|
Acute Coronary Syndrome (ACS) |
Drug: Apixaban Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome. |
Enrollment: | 1715 |
Study Start Date: | May 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: Apixaban
Tablets, Oral, 2.5 mg, twice daily, 26 weeks
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A2: Experimental |
Drug: Apixaban
Tablets, Oral, 10 mg, once daily, 26 weeks
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A3: Placebo Comparator |
Drug: Placebo
Tablets, Oral, 0, twice daily, 26 weeks
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CV185-023 |
Study First Received: | April 10, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00313300 |
Health Authority: | United States: Food and Drug Administration |
Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases Ischemia |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |