Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Phase 2
Completed
- Conditions
- Venous Thromboembolism
- Interventions
- Registration Number
- NCT00913120
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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 hip replacement surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 610
Inclusion Criteria
- Subjects is scheduled for elective primary total hip 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/antiplatelet agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YM150 group-1 YM150 YM150 low dose group YM150 group-2 YM150 YM150 high dose group Placebo group Placebo - Enoxaparin group Enoxaparin -
- Primary Outcome Measures
Name Time Method Overall incidence of venous thromboembolism For 2 weeks
- Secondary Outcome Measures
Name Time Method Incidence of individual venous thromboembolism For 2 weeks Incidence of bleeding events For 2 weeks