YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
Phase 3
Completed
- Conditions
- Venous Thromboembolism
- Interventions
- Drug: YM150
- Registration Number
- NCT01028950
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description YM150 group YM150 -
- Primary Outcome Measures
Name Time Method Composite assessment of VTE events and all cause death Until day 28
- Secondary Outcome Measures
Name Time Method Incidence of bleeding events Until day 28