A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
First received: August 12, 2010
Last updated: February 3, 2015
Last verified: February 2015
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 Intervention Phase
Venous Thromboembolism
Drug: edoxaban
Drug: enoxaparin sodium
Phase 3

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 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)

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Incidence of Subjects With Venous Thromboembolism Events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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:
  • Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 610
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01181167

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

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01181167     History of Changes
Other Study ID Numbers: DU176b-B-J304 
Study First Received: August 12, 2010
Results First Received: January 15, 2015
Last Updated: February 3, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Daiichi Sankyo Inc.:
Venous thromboembolism
enoxaparin sodium
Deep vein thrombosis
factor Xa
total hip arthroplasty

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

ClinicalTrials.gov processed this record on May 26, 2016