A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01203098
First received: September 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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Purpose
The objective of this study is to compare the efficacy, safety at each dose versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
| Condition | Intervention | Phase |
|---|---|---|
|
Anticoagulants Venous Thromboembolism Thromboembolism Thrombosis Enoxaparin Sodium Embolism and Thrombosis Deep Vein Thrombosis DU-176b Edoxaban Factor Xa Oral Arthroplasty, Replacement, Hip |
Drug: DU-176V 15 mg tablets oral, once daily for 2 weeks Drug: DU-176b 30 mg tablets, oral once daily for 2 weeks Drug: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2) |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Proportion of subjects with venous thromboembolism events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 263 |
| Study Start Date: | July 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DU-176b 30 mg | Drug: DU-176b 30 mg tablets, oral once daily for 2 weeks |
| Active Comparator: Enoxaparin sodium | Drug: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous |
| Experimental: DU-176b 15 mg | Drug: DU-176V 15 mg tablets oral, once daily for 2 weeks |
Eligibility| Ages Eligible for Study: | 20 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing unilateral total hip arthroplasty
- Patients who are 20-84 years olds
Exclusion Criteria:
- Subjects with risks of hemorrhage
- Subjects with thromboembolic risks
- Subjects who weigh less than 40 kg
- Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
Contacts and Locations More Information
No publications provided
| Responsible Party: | Masayuki Fukuzawa, Daiichi Sankyo Tokyo, Ltd., Clinical Development Department I |
| ClinicalTrials.gov Identifier: | NCT01203098 History of Changes |
| Other Study ID Numbers: | DU176b-B-J209 |
| Study First Received: | September 14, 2010 |
| Last Updated: | September 14, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Daiichi Sankyo Inc.:
|
prevention venous thromboembolism edoxaban |
Additional relevant MeSH terms:
|
Venous Thrombosis Venous Thromboembolism Embolism Thromboembolism Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013