A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Phase 3
Completed
- Conditions
- Venous Thromboembolism
- Interventions
- Procedure: mechanical prophylaxis
- Registration Number
- NCT00942435
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
- Patients after a major abdominal surgery
- Written informed consent obtained
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YM150 group YM150 - mechanical prophylaxis group mechanical prophylaxis -
- Primary Outcome Measures
Name Time Method Composite assessment of venous thromboembolism events and all causes of death Until day 12
- Secondary Outcome Measures
Name Time Method All cause mortality Until day 28 Incidence of venous thromboembolism Until day 28 Incidence of bleeding events Until day 28