Who is sponsoring NCT00097357?

NCT00097357 is sponsored by Bristol-Myers Squibb.

What condition does NCT00097357 study?

NCT00097357 studies Venous Thrombosis, Pulmonary Embolism.

What drugs are being tested in NCT00097357?

Interventions: Apixaban, Enoxaparin, Warfarin, Enoxaparin Placebo, Apixaban Placebo.

What is the status of NCT00097357?

NCT00097357 is currently COMPLETED.

Last reviewed 2010-02-27 · How we verify

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

NCT00097357 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	1238
Start date	2004-10
Completion	2005-12

Conditions

Venous Thrombosis
Pulmonary Embolism

Interventions

Apixaban
Enoxaparin
Warfarin
Enoxaparin Placebo
Apixaban Placebo

Primary outcomes

Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery — throughout the study

Countries

United States, Argentina, Australia, Canada, Denmark, Israel, Mexico, Poland, Puerto Rico