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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01181141
First received: August 12, 2010
Last updated: February 3, 2015
Last verified: February 2015

August 12, 2010
February 3, 2015
October 2008
August 2009   (final data collection date for primary outcome measure)
The Incidence of Major or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
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.
Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01181141 on ClinicalTrials.gov Archive Site
Proportion of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Venous Thromboembolism
  • Drug: DU-176b (edoxaban)
  • Drug: Enoxaparin sodium 20mg
  • Experimental: DU-176b
    DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery
    Intervention: 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
    Intervention: Drug: Enoxaparin sodium 20mg
Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, Abe K, Tachibana S. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014 Jun;133(6):1016-22. doi: 10.1016/j.thromres.2014.03.009. Epub 2014 Mar 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
February 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01181141
DU176b-B-J303
No
Not Provided
Not Provided
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd.
Not Provided
Principal Investigator: Takeshi Fuji Osaka Kouseinennkin Hospital
Daiichi Sankyo Inc.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP