Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

Astellas

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: YM150

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937911

150-CL-041

Details and patient eligibility

About

The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.

Enrollment: 101 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
• 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, retinopacy, myocardial infarction or stroke
• Subject is receiving anticoagulants/antiplatelet agents
• Subject has a body weight less than 40 kg

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

YM150 group

Experimental group

Treatment:

Drug: YM150