A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery
- Registration Number
- NCT00595426
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 685
Inclusion Criteria
- Subject is scheduled for elective primary knee arthroplasty
- Written Informed consent obtained
Exclusion Criteria
- Subject has documented history of previous VTE
- Subject is considered to be at increased risk of VTE
- Subject has active bleeding or any condition associated with increased risk of bleeding
- Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2. YM150 Dose Y, once daily YM150 - 3. YM150 Dose Y, twice daily YM150 - 4. YM150 Dose Z, once daily YM150 - 5. Warfarin Warfarin various doses 1. YM150 Dose X, twice daily YM150 -
- Primary Outcome Measures
Name Time Method The incidence of total venous thromboembolisms (VTE). 6 Weeks The incidence of bleeding events classified as major by the Adjudication Committee 6 Weeks
- Secondary Outcome Measures
Name Time Method Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause 6 Weeks Incidence of the bleeding types: major, clinically relevant nonmajor, minor 6 Weeks