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

Astellas

Status and phase

Completed

Phase 2

Conditions

Thromboembolism

Treatments

Drug: YM150

Study type

Interventional

Funder types

Industry

Identifiers

NCT00353678

150-CL-008

Details and patient eligibility

About

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.

Enrollment

1,141 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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