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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:
ClinicalTrials.gov Identifier:
NCT01203072
First Posted: September 16, 2010
Last Update Posted: January 26, 2015
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.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
  Purpose
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.

Condition Intervention Phase
Venous Thromboembolism Deep Vein Thrombosis Total Knee Arthroplasty Drug: DU-176b Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • Proportion of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ]

    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


Secondary Outcome Measures:
  • Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding [ Time Frame: 2 weeks ]
    Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug


Enrollment: 523
Study Start Date: July 2006
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DU-176b 5 mg Drug: DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
Other Name: edoxaban
Experimental: DU-176b 15 mg Drug: DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Other Name: edoxaban
Experimental: DU-176b 30 mg Drug: DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Other Name: edoxaban
Experimental: DU-176b 60 mg Drug: DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Other Name: edoxaban
Placebo Comparator: Placebo Drug: Placebo
Matching placebo oral tablets, once daily for 2 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01203072


Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Takeshi Fuji, Director Osaka Koseinekin Hospital
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01203072     History of Changes
Other Study ID Numbers: DU176b-04
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: January 15, 2015
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
prevention
venous thromboembolism
edoxaban
factor Xa

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants