Back to resultsPrevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM150
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring YM150, Bleeding, Anticoagulant, Venous thromboembolism, FXa inhibitor
Eligibility Criteria
Inclusion Criteria:
- Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture 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
- Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
- Subject is receiving anticoagulants/antiplatelet agents
- Subject has a body weight less than 40 kg
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
YM150 group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of venous thromboembolism
Secondary Outcome Measures
Incidence of deep vein thrombosis
Incidence of pulmonary embolism
All cause mortality
Incidence of bleeding event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00937911
Brief Title
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Official Title
YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
YM150, Bleeding, Anticoagulant, Venous thromboembolism, FXa inhibitor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YM150 group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
oral
Primary Outcome Measure Information:
Title
Incidence of venous thromboembolism
Time Frame
Until day 12
Secondary Outcome Measure Information:
Title
Incidence of deep vein thrombosis
Time Frame
Until day 35
Title
Incidence of pulmonary embolism
Time Frame
Until day 35
Title
All cause mortality
Time Frame
Until day 35
Title
Incidence of bleeding event
Time Frame
Until day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture 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
Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
Subject is receiving anticoagulants/antiplatelet agents
Subject has a body weight less than 40 kg
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
12. IPD Sharing Statement
Learn more about this trial
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
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