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

August 12, 2010
August 12, 2010
October 2008
August 2009   (final data collection date for primary outcome measure)
Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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
    Intervention: Drug: DU-176b (edoxaban)
  • Active Comparator: Enoxaparin sodium
    Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection
    Intervention: Drug: Enoxaparin sodium 20mg
Not Provided

*   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
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01181141
DU176b-B-J303
No
Kenichi Sakakura, Daiichi Sankyo, Tokyo, LTD., Clinical Development Dept. 1
Daiichi Sankyo Inc.
Daiichi Sankyo Co., Ltd.
Principal Investigator: Takeshi Fuji Osaka Kouseinennkin Hospital
Daiichi Sankyo Inc.
August 2010

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