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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 : February 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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 hip arthroplasty.

Condition or disease Intervention/treatment Phase
Prevention Venous Thromboembolism Drug: edoxaban Drug: enoxaparin sodium Phase 3

Study Design

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
Primary Completion Date : January 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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: 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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT01181167


Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Takeshi Fuji Osaka Koseinenkin Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01181167     History of Changes
Other Study ID Numbers: DU176b-B-J304
First Posted: August 13, 2010    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Anticoagulants
Venous thromboembolism
Thromboembolism
Thrombosis
enoxaparin sodium
Embolism
Deep vein thrombosis
DU-176b
edoxaban
factor Xa
total hip arthroplasty

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Enoxaparin
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents