Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

Phase 2

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: YM150; Drug: Placebo; Drug: Enoxaparin

• Registration Number: NCT00917254
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-14
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

• Subjects is scheduled for elective primary total knee replacement 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, retinopathy, hypertension, or thrombocytopenia
• Subject is receiving anticoagulants/antiplatelets

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YM150 group-1	YM150	YM150 low dose group
YM150 group-2	YM150	YM150 high dose group
Placebo group	Placebo	-
Enoxaparin group	Enoxaparin	-

Primary Outcome Measures

Name	Time	Method
Overall incidence of venous thromboembolism	2 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of individual venous thromboembolism	2 weeks
Incidence of bleeding events	2 weeks