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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.
 
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

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 3, 2009
Last Update Posted Date June 9, 2010
Study Start Date  ICMJE May 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
Overall incidence of venous thromboembolism [ Time Frame: For 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • Incidence of individual venous thromboembolism [ Time Frame: For 2 weeks ]
  • Incidence of bleeding events [ Time Frame: For 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Official Title  ICMJE Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE
  • Drug: YM150
    oral
  • Drug: Placebo
    oral
  • Drug: Enoxaparin
    injection
Study Arms  ICMJE
  • Experimental: YM150 group-1
    YM150 low dose group
    Intervention: Drug: YM150
  • Experimental: YM150 group-2
    YM150 high dose group
    Intervention: Drug: YM150
  • Placebo Comparator: Placebo group
    Intervention: Drug: Placebo
  • Active Comparator: Enoxaparin group
    Intervention: Drug: Enoxaparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
610
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2009)
580
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913120
Other Study ID Numbers  ICMJE 150-CL-027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Astellas Pharma, Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Use Central Contact Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP