A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery

Astellas Pharma Europe B.V.0 sites1,992 target enrollmentApril 2009

ConditionsVenous Thromboembolism Arthroplasty, Replacement, Hip

InterventionsYM150 enoxaparin

DrugsYM150 enoxaparin

Overview

Phase: Phase 2
Intervention: YM150
Conditions: Venous Thromboembolism
Sponsor: Astellas Pharma Europe B.V.
Enrollment: 1992
Primary Endpoint: Incidence of symptomatic Venous Thromboembolisms and death from all causes
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

August 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Europe B.V.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1. YM150, Dose X, twice daily

Intervention: YM150

2, YM150, Dose X, once daily

Intervention: YM150

3. YM150, Dose Y, twice daily

Intervention: YM150

4. YM150, Dose Y, once daily

Intervention: YM150

5. Enoxaparin

Intervention: enoxaparin

Outcomes

Primary Outcomes

Incidence of symptomatic Venous Thromboembolisms and death from all causes

Time Frame: 12 days

Secondary Outcomes

Incidence of Bleeding events(During the treatment period, follow-up period and entire study period)
Incidence of all Venous Thromboembolic events(Until day 12, during the treatment period, follow-up period and entire study period)