Back to resultsPrevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism
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, VTE, FXa inhibitor, Venous thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
- 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, retinopathy, 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
Joint incidence of deep vein thromboembolism or pulmonary thromboembolism
Secondary Outcome Measures
Incidence of each thromboembolism
All cause mortality
Incidence of bleeding event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00937820
Brief Title
Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism
Official Title
YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 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 52 weeks in patients with a history of venous thromboembolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
YM150, Bleeding, VTE, FXa inhibitor, Venous thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (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
Joint incidence of deep vein thromboembolism or pulmonary thromboembolism
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Incidence of each thromboembolism
Time Frame
52 weeks
Title
All cause mortality
Time Frame
52 weeks
Title
Incidence of bleeding event
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
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, retinopathy, 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
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Touhoku
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism
We'll reach out to this number within 24 hrs