DU-176b Phase 3 Clinical Study (Venous Thromboembolism) -Randomized Double-Blind Study of DU-176b in Patients Undergoing Total Knee Arthroplasty with Enoxaparin as an Active Control
Phase 3
- Conditions
- Patients undergoing total knee arthroplasty
- Registration Number
- JPRN-jRCT2080220701
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
Patients undergoing unilateral total knee arthroplasty
Patients who are 20-84 years olds
Exclusion Criteria
Subjects with risks of hemorrhage
Subjects with thromboembolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with venous thromboembolism events
- Secondary Outcome Measures
Name Time Method Proportion of subjects with bleeding events