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

Astellas

Status and phase: Completed; Phase 3; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: Placebo; Drug: Enoxaparin; Drug: YM150

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917254

150-CL-031

Details and patient eligibility

About

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.

Enrollment: 369 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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369 participants in 4 patient groups, including a placebo group

YM150 group-1

Experimental group

Description:

YM150 low dose group

Treatment:

Drug: YM150

YM150 group-2

Experimental group

Description:

YM150 high dose group

Treatment:

Drug: YM150

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo

Enoxaparin group

Active Comparator group

Treatment:

Drug: Enoxaparin