A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Inclusion Criteria:

• Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• Subjects with risks of hemorrhage
• Subjects with thromboembolic risks
• Subjects who weigh less than 40 kg
• Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.