A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
NCT ID: NCT01203098
Last Updated: 2019-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
264 participants
INTERVENTIONAL
2008-07-31
2009-06-30
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 30mg once daily
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
DU-176b 30mg
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Enoxaparin sodium twice daily
Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
Enoxaparin sodium 20 mg (=2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
DU-176b 15mg once daily
DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
DU-176b 15mg
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Interventions
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DU-176b 15mg
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
DU-176b 30mg
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Enoxaparin sodium 20 mg (=2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are 20-84 years olds
Exclusion Criteria
2. Subjects with thromboembolic risks
3. Subjects who weigh less than 40 kg
4. Subjects who are pregnant or 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
Role: PRINCIPAL_INVESTIGATOR
Osaka Koseinenkin Hospital
Locations
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Osaka, , Japan
Tokyo, , Japan
Kaohsiung City, , Taiwan
Countries
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References
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Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. J Arthroplasty. 2014 Dec;29(12):2439-46. doi: 10.1016/j.arth.2014.05.029. Epub 2014 Jun 9.
Other Identifiers
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DU176b-B-J209
Identifier Type: -
Identifier Source: org_study_id
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