NCT00097357

BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,238 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.

Conditions

• Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Apixaban	Tablets, Oral, 12 +/- 2 days
DRUG	Enoxaparin	Injection, SQ, Q12H, 12 +/- 2 days
DRUG	Warfarin	Tablets, Oral, QD, 12 +/- 2 days
DRUG	Enoxaparin Placebo	Injection, SQ, BID, 12 +/- 2 days
DRUG	Apixaban Placebo	Tablets, Oral, BID, 12 +/- 2 days

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2004-11-23
• Last updated: 2010-03-02

Locations

147 sites across 9 countries: United States, Argentina, Australia, Canada, Denmark, Israel, Mexico, Poland, Puerto Rico