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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00917254
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 16, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: YM150 Drug: Placebo Drug: Enoxaparin Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -
Study Start Date : May 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: YM150 group-1
YM150 low dose group
Drug: YM150
Experimental: YM150 group-2
YM150 high dose group
Drug: YM150
Placebo Comparator: Placebo group Drug: Placebo
Active Comparator: Enoxaparin group Drug: Enoxaparin

Primary Outcome Measures :
  1. Overall incidence of venous thromboembolism [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Incidence of individual venous thromboembolism [ Time Frame: 2 weeks ]
  2. Incidence of bleeding events [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00917254

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Touhoku, Japan
Changhua, Taiwan
Chia-Yi, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Bangkok, Thailand
Chiangmai, Thailand
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00917254     History of Changes
Other Study ID Numbers: 150-CL-031
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
Knee Replacement
FXa inhibitor

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action