Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
- Registration Number
- NCT00408239
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 367
Inclusion Criteria
- Scheduled for elective primary total knee replacement surgery
- Legal minimum age requirement ( country-specific)
- Written informed consent has been obtained
Exclusion Criteria
-
Documented history or considered to be at increased risk of venous thromboembolism
-
Subjects considered to be at increased risk of bleeding:
- Known hemorrhagic disorder and/or coagulation disorder
- Thrombocytopenia
- Clinically important bleeding occurred within 3 months prior to the screening visit
-
Acute bacterial endocarditis
-
Severe hypertension
-
Retinopathy
-
Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 YM150 Dose regimen 1 3 YM150 Dose regimen 2 2 enoxaparin -
- Primary Outcome Measures
Name Time Method All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment 2 Weeks
- Secondary Outcome Measures
Name Time Method Venous thromboembolism and/or bleeds 2 Weeks Other safety assessments 2 Weeks PK, PD variables 2 Weeks