Trials / Completed
CompletedNCT00423319
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5,407 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enoxaparin | Subcutaneous, 40 mg, once daily, 5 weeks |
| DRUG | Apixaban | Oral tablets, 2.5 mg, twice daily, 5weeks |
| DRUG | Enoxaparin-matching placebo | Administered as injection |
| DRUG | Apixaban-matching placebo | Administered as oral tablets |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2009-09-01
- Completion
- 2009-09-01
- First posted
- 2007-01-18
- Last updated
- 2014-05-14
- Results posted
- 2014-05-14
Locations
143 sites across 21 countries: United States, Argentina, Australia, Belgium, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Mexico, Norway, Poland, Romania, Russia, Spain, Sweden, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00423319. Inclusion in this directory is not an endorsement.