Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bristol-Myers Squibb |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00457002 |
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 within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
Condition | Intervention | Phase |
---|---|---|
Venous Thrombosis Pulmonary Embolism |
Drug: Apixaban Drug: Enoxaparin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase 3 Randomized, Double-Blind, Parallel-Group, Multi-Center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization. |
Estimated Enrollment: | 6524 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental
While hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg) |
Drug: Apixaban
Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days |
Arm 2: Active Comparator
While hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral) |
Drug: Enoxaparin
Enoxaparin: Once daily, 6-14 days Placebo: Twice daily, 30 days |
Ages Eligible for Study: | 40 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: | CV185-036 |
Study First Received: | April 4, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00457002 |
Health Authority: | United States: Food and Drug Administration |
Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases Vascular Diseases |
Venous Thrombosis Venous Thromboembolism Thromboembolism Thrombosis Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |