Overview

Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma Europe B.V.
Treatments:
Darexaban
Factor Xa Inhibitors
Criteria
Inclusion Criteria:

- Scheduled for elective primary hip replacement

- Age 18 years or over

- Written informed consent obtained

Exclusion Criteria:

- Documented history or considered at increased risk of venous thromboembolism

- Subjects considered at increased risk of bleeding

- Surgery planned for contralateral hip at the same time or within 10 weeks after
enrolment

- Concomitant use of anticoagulants/ antiplatelet agents