Back to resultsPrevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
Placebo
Enoxaparin
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring YM150, FXa inhibitor, Thrombosis, Anticoagulant, Venous thromboembolism, Arthroplasty, replacement, hip
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
YM150 group-1
YM150 group-2
Placebo group
Enoxaparin group
Arm Description
YM150 low dose group
YM150 high dose group
Outcomes
Primary Outcome Measures
Overall incidence of venous thromboembolism
Secondary Outcome Measures
Incidence of individual venous thromboembolism
Incidence of bleeding events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913120
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
YM150, FXa inhibitor, Thrombosis, Anticoagulant, Venous thromboembolism, Arthroplasty, replacement, hip
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
610 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM150 group-1
Arm Type
Experimental
Arm Description
YM150 low dose group
Arm Title
YM150 group-2
Arm Type
Experimental
Arm Description
YM150 high dose group
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
Enoxaparin group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
injection
Primary Outcome Measure Information:
Title
Overall incidence of venous thromboembolism
Time Frame
For 2 weeks
Secondary Outcome Measure Information:
Title
Incidence of individual venous thromboembolism
Time Frame
For 2 weeks
Title
Incidence of bleeding events
Time Frame
For 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
City
Touhoku
Country
Japan
City
Daegu
Country
Korea, Republic of
City
Jeonnam
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Changhua
Country
Taiwan
City
Chiayi
Country
Taiwan
City
Taichung
Country
Taiwan
City
Bangkok
Country
Thailand
City
Chiangmai
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
We'll reach out to this number within 24 hrs