Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
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ClinicalTrials.gov Identifier: NCT01181141 |
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 |
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Venous Thromboembolism | Drug: DU-176b (edoxaban) Drug: Enoxaparin sodium 20mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial) |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
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: DU-176b (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 20mg |
- The Incidence of Major or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ]Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.
- Proportion of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)
Exclusion Criteria:
- Subjects with risks of hemorrhage
- Subjects with thrombolic 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): NCT01181141
Japan | |
Osaka, Japan |
Principal Investigator: | Takeshi Fuji | Osaka Kouseinennkin Hospital |
Responsible Party: | Daiichi Sankyo Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01181141 |
Other Study ID Numbers: |
DU176b-B-J303 |
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 Enoxaparin sodium venous thromboembolism. thromboembolism Thrombosis deep vein thrombosis |
DU-176b Edoxaban factor Xa hip fracture surgery embolism |
Thromboembolism Venous Thromboembolism Hip Fractures Fractures, Bone Wounds and Injuries Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Femoral Fractures Hip Injuries Leg Injuries |
Enoxaparin Edoxaban Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |