Status:
COMPLETED
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
Eligibility Criteria
Inclusion
- Scheduled for elective primary total knee replacement surgery
- Legal minimum age requirement ( country-specific)
- Written informed consent has been obtained
Exclusion
- Documented history or considered to be at increased risk of venous thromboembolism
- Subjects considered to be at increased risk of bleeding:
- Known hemorrhagic disorder and/or coagulation disorder
- Thrombocytopenia
- Clinically important bleeding occurred within 3 months prior to the screening visit
- Acute bacterial endocarditis
- Severe hypertension
- Retinopathy
- Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00408239
Start Date
December 1 2006
End Date
March 1 2009
Last Update
December 19 2011
Active Locations (19)
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1
Jakarta, Indonesia, 14460
2
Chubu Region, Japan
3
Chugoku Region, Japan
4
Kansai Region, Japan