YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Darexaban

Criteria

Inclusion Criteria:

• Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks

• Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization

• Written informed consent obtained

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 obtaining informed consent

• 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

• Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods