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

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

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 3, 2009
• Last Update Posted Date: June 9, 2010
• Study Start Date: May 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 2, 2009): Overall incidence of venous thromboembolism [ Time Frame: For 2 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Venous Thromboembolism

Intervention

• Drug: YM150
  oral
• Drug: Placebo
  oral
• Drug: Enoxaparin
  injection

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 18, 2010): 610
• Original Estimated Enrollment (submitted: June 2, 2009): 580
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, Korea, Republic of, Taiwan, Thailand

Administrative Information

• NCT Number: NCT00913120
• Other Study ID Numbers: 150-CL-027
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Astellas Pharma, Inc
• Study Sponsor: Astellas Pharma Inc
• Collaborators: Not Provided

Investigators

• Study Chair: Use Central Contact; Astellas Pharma Inc

• PRS Account: Astellas Pharma Inc
• Verification Date: June 2010