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

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ClinicalTrials.gov Identifier: NCT00913120
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 9, 2010
Sponsor:
Information provided by:
Astellas Pharma Inc

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00913120


Locations
Japan
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
Taiwan
Changhua, Taiwan
Chiayi, Taiwan
Taichung, Taiwan
Thailand
Bangkok, Thailand
Chiangmai, Thailand
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00913120     History of Changes
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:
YM150
FXa inhibitor
Thrombosis
 Anticoagulant
Venous thromboembolism
Arthroplasty, replacement, hip

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