A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
NCT ID: NCT01203072
Last Updated: 2019-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
523 participants
INTERVENTIONAL
2006-07-31
2008-07-31
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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DU-176b 5 mg
DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176b 15 mg
DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176b 30 mg
DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176b 60 mg
DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Placebo
Placebo
Matching placebo oral tablets, once daily for 2 weeks
Interventions
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DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Placebo
Matching placebo oral tablets, once daily for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* thromboembolic risks
* weight less than 40 kg
* pregnant, suspect pregnancy, or subjects who want to become pregnant
20 Years
84 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Takeshi Fuji, Director
Role: PRINCIPAL_INVESTIGATOR
Osaka Koseinekin Hospital
Locations
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Osaka, , Japan
Tokyo, , Japan
Countries
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Other Identifiers
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DU176b-04
Identifier Type: -
Identifier Source: org_study_id
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