A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01181102
First received: August 12, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2010 | ||||
| Last Updated Date | August 12, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Proportion of subjects with venous thromboembolism events. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty | ||||
| Official Title ICMJE | A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial) | ||||
| Brief Summary | The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 716 | ||||
| Completion Date | February 2010 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 84 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan, Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01181102 | ||||
| Other Study ID Numbers ICMJE | DU176b-B-J302 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kei Ibusuki, Daiichi Sankyo, Tokyo, LTD., Cliinical Development Department I | ||||
| Study Sponsor ICMJE | Daiichi Sankyo Inc. | ||||
| Collaborators ICMJE | Daiichi Sankyo Co., Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Daiichi Sankyo Inc. | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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