Status:
COMPLETED
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.
Eligibility Criteria
Inclusion
- Subjects is scheduled for elective primary total knee replacement 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, retinopathy, hypertension, or thrombocytopenia
- Subject is receiving anticoagulants/antiplatelets
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00917254
Start Date
May 1 2009
End Date
January 1 2010
Last Update
June 16 2010
Active Locations (13)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan