Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
NCT ID: NCT00917254
Last Updated: 2010-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
369 participants
INTERVENTIONAL
2009-05-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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YM150 group-1
YM150 low dose group
YM150
oral
YM150 group-2
YM150 high dose group
YM150
oral
Placebo group
Placebo
oral
Enoxaparin group
Enoxaparin
injection
Interventions
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YM150
oral
Placebo
oral
Enoxaparin
injection
Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained before screening
Exclusion Criteria
* 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/antiplatelets
20 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma, Inc
Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chugoku, , Japan
Chūbu, , Japan
Hokkaido, , Japan
Kansai, , Japan
Kantou, , Japan
Kyusyu, , Japan
Tōhoku, , Japan
Changhua, , Taiwan
Chiayi City, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
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Other Identifiers
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150-CL-031
Identifier Type: -
Identifier Source: org_study_id
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