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Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181141
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : January 26, 2015
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: DU-176b (edoxaban) Drug: Enoxaparin sodium 20mg Phase 3

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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

Resource links provided by the National Library of Medicine


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
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
Drug: Enoxaparin sodium 20mg



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Japan
Osaka, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Principal Investigator: Takeshi Fuji Osaka Kouseinennkin Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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/
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Anticoagulants
Enoxaparin sodium
venous thromboembolism.
thromboembolism
Thrombosis
deep vein thrombosis
DU-176b
Edoxaban
factor Xa
hip fracture surgery
embolism
Additional relevant MeSH terms:
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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