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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01181167
First received: August 12, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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
Prevention
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:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Proportion of subjects with venous thromboembolism events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with bleeding events [ 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
 Drug: edoxaban
Active Comparator: enoxaparin sodium
enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection
 Drug: enoxaparin sodium

  Eligibility

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

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

No publications provided

Responsible Party: Masayuki Fukuzawa, Daiichi Sankyo, Tokyo, LTD., Clinical Development Department I
ClinicalTrials.gov Identifier: NCT01181167     History of Changes
Other Study ID Numbers: DU176b-B-J304
Study First Received: August 12, 2010
Last Updated: August 12, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Daiichi Sankyo Inc.:
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
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013