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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01181141
First received: August 12, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention Phase
Venous Thromboembolism
 Drug: DU-176b (edoxaban)
Drug: Enoxaparin sodium 20mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

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 bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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

Enrollment: 92
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DU-176b
DU-176b oral tablets, 30 mg., taken once daily
 Drug: DU-176b (edoxaban)
Active Comparator: Enoxaparin sodium
Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection
 Drug: Enoxaparin sodium 20mg

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181141

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

No publications provided

Responsible Party: Kenichi Sakakura, Daiichi Sankyo, Tokyo, LTD., Clinical Development Dept. 1
ClinicalTrials.gov Identifier: NCT01181141     History of Changes
Other Study ID Numbers: DU176b-B-J303
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
Enoxaparin sodium
venous thromboembolism.
thromboembolism
Thrombosis
deep vein thrombosis
 DU-176b
Edoxaban
factor Xa
hip fracture surgery
embolism

Additional relevant MeSH terms:
Hip Fractures
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
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 22, 2013