Status:
COMPLETED
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Europe B.V.
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
Eligibility Criteria
Inclusion
- Scheduled for elective primary hip replacement
- Age 18 years or over
- Written informed consent obtained
Exclusion
- Documented history or considered at increased risk of venous thromboembolism
- Subjects considered at increased risk of bleeding
- Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
- Concomitant use of anticoagulants/ antiplatelet agents
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
1141 Patients enrolled
Trial Details
Trial ID
NCT00353678
Start Date
June 1 2006
End Date
August 1 2007
Last Update
March 21 2013
Active Locations (79)
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1
Innsbruck, Austria, 6020
2
Vienna, Austria, 1090
3
Vienna, Austria, 1130
4
Foča, Bosnia and Herzegovina, 73300