Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
- Registration Number
- NCT00937911
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
Inclusion Criteria
- Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
- Written informed consent obtained before screening
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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
- Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
- Subject is receiving anticoagulants/antiplatelet agents
- Subject has a body weight less than 40 kg
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description YM150 group YM150 -
- Primary Outcome Measures
Name Time Method Incidence of venous thromboembolism Until day 12
- Secondary Outcome Measures
Name Time Method Incidence of deep vein thrombosis Until day 35 Incidence of pulmonary embolism Until day 35 All cause mortality Until day 35 Incidence of bleeding event Until day 35