Status:
COMPLETED
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
- Written informed consent obtained before screening
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00937911
Start Date
June 1 2009
End Date
April 1 2010
Last Update
June 16 2010
Active Locations (8)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan