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. Identifier: NCT01181141
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : January 26, 2015
Last Update Posted : February 23, 2015
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

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 ]

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

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 identifier (NCT number): NCT01181141

Osaka, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Principal Investigator: Takeshi Fuji Osaka Kouseinennkin Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Co., Ltd. Identifier: NCT01181141     History of Changes
Other Study ID Numbers: DU176b-B-J303
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. ):
Enoxaparin sodium
venous thromboembolism.
deep vein thrombosis
factor Xa
hip fracture surgery

Additional relevant MeSH terms:
Venous Thromboembolism
Hip Fractures
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents