Back to resultsYM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
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, Deep Vein Thrombosis, Venous thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
- Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
- Written informed consent obtained
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 obtaining informed consent
- 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
- Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
YM150 group
Arm Description
Outcomes
Primary Outcome Measures
Composite assessment of VTE events and all cause death
Secondary Outcome Measures
Incidence of bleeding events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01028950
Brief Title
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
Official Title
A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 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
To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.
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, Deep Vein Thrombosis, Venous thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (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
Composite assessment of VTE events and all cause death
Time Frame
Until day 28
Secondary Outcome Measure Information:
Title
Incidence of bleeding events
Time Frame
Until day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
Written informed consent obtained
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 obtaining informed consent
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
Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods
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
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
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