NCT00452530

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,221 (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 prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Enoxaparin	40 mg, administered once daily by subcutaneous injection, for 12 days
DRUG	Apixaban	2.5 mg, administered twice daily as tablets, for 12 days
DRUG	Enoxaparin-matching placebo	Administered once daily by subcutaneous injection
DRUG	Apixaban-matching placebo	Oral tablet administered twice daily

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-03-27
• Last updated: 2014-07-09
• Results posted: 2014-05-13

Locations

122 sites across 27 countries: Austria, Belgium, Brazil, Chile, China, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Norway, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Ukraine, United Kingdom