Status:
COMPLETED
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.
Eligibility Criteria
Inclusion
- Patients after a major abdominal surgery
- Written informed consent obtained
Exclusion
- Subject has history of symptomatic 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 active bacterial endocarditis
- Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
- Subject is receiving anticoagulants/antiplatelet agents
- Subject has a thrombocytopenia
- Body weight less than 40 kg at the screening
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00942435
Start Date
June 1 2009
End Date
April 1 2010
Last Update
June 16 2010
Active Locations (6)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan