A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
Phase 2
Completed
- Conditions
- Venous ThromboembolismArthroplasty, Replacement, Hip
- Interventions
- Registration Number
- NCT00902928
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1992
Inclusion Criteria
- Subject is scheduled for elective hip replacement surgery
Exclusion Criteria
- Subject has active bleeding or any condition associated with increased risk of bleeding
- Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
- Subject has had an MI or stroke within 3 months before planned hip replacement surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. YM150, Dose X, twice daily YM150 - 2, YM150, Dose X, once daily YM150 - 3. YM150, Dose Y, twice daily YM150 - 4. YM150, Dose Y, once daily YM150 - 5. Enoxaparin enoxaparin -
- Primary Outcome Measures
Name Time Method Incidence of symptomatic Venous Thromboembolisms and death from all causes 12 days
- Secondary Outcome Measures
Name Time Method Incidence of Bleeding events During the treatment period, follow-up period and entire study period Incidence of all Venous Thromboembolic events Until day 12, during the treatment period, follow-up period and entire study period