A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery (ONYX-3)

Astellas

Status and phase: Completed; Phase 3; Phase 2

Conditions: Arthroplasty, Replacement, Hip; Venous Thromboembolism

Treatments: Drug: YM150; Drug: enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902928

150-CL-040

2008-004416-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

Enrollment: 1,992 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is scheduled for elective hip replacement surgery

Exclusion criteria

• Subject has active bleeding or any condition associated with increased risk of bleeding
• Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
• Subject has had an MI or stroke within 3 months before planned hip replacement surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,992 participants in 5 patient groups

1. YM150, Dose X, twice daily

Experimental group

Treatment:

Drug: YM150

2, YM150, Dose X, once daily

Experimental group

Treatment:

Drug: YM150

3. YM150, Dose Y, twice daily

Experimental group

Treatment:

Drug: YM150

4. YM150, Dose Y, once daily

Experimental group

Treatment:

Drug: YM150

5. Enoxaparin

Active Comparator group

Treatment:

Drug: enoxaparin