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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014