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Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip 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: NCT00913120
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 9, 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 hip replacement surgery.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 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 Hip Replacement Surgery
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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: For 2 weeks ]

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subjects is scheduled for elective primary total hip 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/antiplatelet agents

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): NCT00913120

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Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shikoku, Japan
Touhoku, Japan
Korea, Republic of
Daegu, Korea, Republic of
Jeonnam, Korea, Republic of
Seoul, Korea, Republic of
Changhua, Taiwan
Chiayi, Taiwan
Taichung, Taiwan
Bangkok, Thailand
Chiangmai, Thailand
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Use Central Contact Astellas Pharma Inc
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Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00913120    
Other Study ID Numbers: 150-CL-027
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010
Keywords provided by Astellas Pharma Inc:
FXa inhibitor
Venous thromboembolism
Arthroplasty, replacement, hip
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action