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
  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
DU-176b
Factor Xa
Drug: DU-176b
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.:

Primary Outcome Measures:
  • Proportion of subjects with venous thromboembolism events. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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
Experimental: DU-176b 15 mg Drug: DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Experimental: DU-176b 30 mg Drug: DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Experimental: DU-176b 60 mg Drug: DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Placebo Comparator: Placebo Drug: Placebo
Matching placebo oral tablets, once daily for 2 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203072

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

No publications provided

Responsible Party: Kei Ibusuki, Daiichi Sankyo, Ltd.,Clinical Development Department I
ClinicalTrials.gov Identifier: NCT01203072     History of Changes
Other Study ID Numbers: DU176b-04
Study First Received: September 14, 2010
Last Updated: September 14, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Daiichi Sankyo Inc.:
prevention
venous thromboembolism
edoxaban

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014