A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01203072
First received: September 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 14, 2010
September 14, 2010
July 2006
September 2007   (final data collection date for primary outcome measure)
Proportion of subjects with venous thromboembolism events. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)

The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Total Knee Arthroplasty
  • DU-176b
  • Factor Xa
  • Drug: DU-176b
    DU-176b 5mg tablets oral, once daily for 2 weeks
  • Drug: DU-176b
    DU-176b 15mg tablets, oral once daily for 2 weeks
  • Drug: DU-176b
    DU-176b 30 mg tablets, oral, once daily for 2 weeks
  • Drug: DU-176b
    DU-176b 60 mg tablets, oral, once daily for 2 weeks
  • Drug: Placebo
    Matching placebo oral tablets, once daily for 2 weeks
  • Experimental: DU-176b 5 mg
    Intervention: Drug: DU-176b
  • Experimental: DU-176b 15 mg
    Intervention: Drug: DU-176b
  • Experimental: DU-176b 30 mg
    Intervention: Drug: DU-176b
  • Experimental: DU-176b 60 mg
    Intervention: Drug: DU-176b
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
523
July 2008
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

  • risks of hemorrhage
  • thromboembolic risks
  • weight less than 40 kg
  • pregnant, suspect pregnancy, or subjects who want to become pregnant
Both
20 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01203072
DU176b-04
Yes
Kei Ibusuki, Daiichi Sankyo, Ltd.,Clinical Development Department I
Daiichi Sankyo Inc.
Daiichi Sankyo Co., Ltd.
Principal Investigator: Takeshi Fuji, Director Osaka Koseinekin Hospital
Daiichi Sankyo Inc.
September 2010

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