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

Primary Purpose

Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
DU-176b
DU-176b
DU-176b
DU-176b
Placebo
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring prevention, venous thromboembolism, edoxaban, factor Xa

Eligibility Criteria

20 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

DU-176b 5 mg

DU-176b 15 mg

DU-176b 30 mg

DU-176b 60 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Subjects With Venous Thromboembolism Events.
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
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug

Full Information

First Posted
September 14, 2010
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01203072
Brief Title
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty
Keywords
prevention, venous thromboembolism, edoxaban, factor Xa

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
523 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DU-176b 5 mg
Arm Type
Experimental
Arm Title
DU-176b 15 mg
Arm Type
Experimental
Arm Title
DU-176b 30 mg
Arm Type
Experimental
Arm Title
DU-176b 60 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DU-176b
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b 5mg tablets oral, once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
DU-176b
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b 15mg tablets, oral once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
DU-176b
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
DU-176b
Other Intervention Name(s)
edoxaban
Intervention Description
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo oral tablets, once daily for 2 weeks
Primary Outcome Measure Information:
Title
Proportion of Subjects With Venous Thromboembolism Events.
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
Description
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Fuji, Director
Organizational Affiliation
Osaka Koseinekin Hospital
Official's Role
Principal Investigator
Facility Information:
City
Osaka
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

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