A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
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ClinicalTrials.gov Identifier: NCT01181167 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Results First Posted : January 26, 2015
Last Update Posted : March 5, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention Venous Thromboembolism | Drug: edoxaban Drug: enoxaparin sodium | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 610 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | 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 Hip Arthroplasty (STARS J-5 Trial) |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
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Experimental: DU-176b
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
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Drug: edoxaban |
Active Comparator: enoxaparin sodium
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
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Drug: enoxaparin sodium |
- Incidence of Subjects With Venous Thromboembolism Events [ Time Frame: 2 weeks ]
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.
- Lower extremity DVT confirmed by bilateral venography at the end of study treatment
- Definite diagnosis of symptomatic PE
- Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
- Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ]

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Ages Eligible for Study: | 20 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing unilateral total hip arthroplasty
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181167
Japan | |
Osaka, Japan | |
Tokyo, Japan |
Principal Investigator: | Takeshi Fuji | Osaka Koseinenkin Hospital |
Responsible Party: | Daiichi Sankyo Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01181167 |
Other Study ID Numbers: |
DU176b-B-J304 |
First Posted: | August 13, 2010 Key Record Dates |
Results First Posted: | January 26, 2015 |
Last Update Posted: | March 5, 2019 |
Last Verified: | February 2015 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. |
Access Criteria: | Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
Anticoagulants Venous thromboembolism Thromboembolism Thrombosis enoxaparin sodium Embolism |
Deep vein thrombosis DU-176b edoxaban factor Xa total hip arthroplasty |
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Enoxaparin Edoxaban Anticoagulants |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |