Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Darexaban; Enoxaparin

Criteria

Inclusion Criteria:

• Subjects is scheduled for elective primary total knee replacement surgery

• Written informed consent obtained before screening

Exclusion Criteria:

• Subject has history of deep vein thrombosis and/or pulmonary embolism

• Subject has a hemorrhagic disorder and/or coagulation disorder

• Subject has had clinically important bleeding occurred within 90 days prior to the screening visit

• Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia

• Subject is receiving anticoagulants/antiplatelets