Status:
COMPLETED
Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism
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 52 weeks in patients with a history of venous thromboembolism.
Eligibility Criteria
Inclusion
- Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
- 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, retinopathy, 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 :
December 1 2010
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00937820
Start Date
June 1 2009
End Date
December 1 2010
Last Update
January 6 2011
Active Locations (5)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Kansai, Japan
4
Kantou, Japan