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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00452530 |
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots.
The safety of apixaban will also be studied.
Condition | Intervention | Phase |
---|---|---|
Deep Vein Thrombosis Pulmonary Embolism |
Drug: Enoxaparin + Placebo Drug: Apixaban + Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Double-Blind, Active-Controlled (Enoxaparin 40 mg QD), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study) |
Estimated Enrollment: | 3058 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Active Comparator
+ placebo
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Drug: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 12 days
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A2: Experimental
+ placebo
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Drug: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days
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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: | CV185-047, EUdraCT: 2006-006896-19 |
Study First Received: | March 23, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00452530 |
Health Authority: | United States: Food and Drug Administration |
Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases |
Vascular Diseases Venous Thrombosis Thrombosis Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |