Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Darexaban

Criteria

Inclusion Criteria:

• Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis

• Written informed consent obtained before screening

Exclusion Criteria:

• 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