A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Astellas

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Procedure: mechanical prophylaxis; Drug: YM150

Study type: Interventional

Funder types: Industry

Identifiers

NCT00942435

150-CL-042

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

YM150 group

Experimental group

Treatment:

Drug: YM150

mechanical prophylaxis group

Active Comparator group

Treatment:

Procedure: mechanical prophylaxis