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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01203072
First received: September 14, 2010
Last updated: January 15, 2015
Last verified: January 2015

September 14, 2010
January 15, 2015
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 ]

The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.

  • Lower extremity DVT confirmed by bilateral venography at the end of study treatment
  • Definite diagnosis of symptomatic PE
  • Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
Proportion of subjects with venous thromboembolism events. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01203072 on ClinicalTrials.gov Archive Site
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug
Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
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
  • Drug: DU-176b
    DU-176b 5mg tablets oral, once daily for 2 weeks
    Other Name: edoxaban
  • Drug: DU-176b
    DU-176b 15mg tablets, oral once daily for 2 weeks
    Other Name: edoxaban
  • Drug: DU-176b
    DU-176b 30 mg tablets, oral, once daily for 2 weeks
    Other Name: edoxaban
  • Drug: DU-176b
    DU-176b 60 mg tablets, oral, once daily for 2 weeks
    Other Name: edoxaban
  • 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
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
Daiichi Sankyo Co., Ltd.
Not Provided
Principal Investigator: Takeshi Fuji, Director Osaka Koseinekin Hospital
Daiichi Sankyo Inc.
January 2015

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