Overview

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

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Darexaban
Criteria
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