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

February 8, 2019 updated by: Daiichi Sankyo Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

523

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo oral tablets, once daily for 2 weeks
Experimental: DU-176b 5 mg
Drug: DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Experimental: DU-176b 15 mg
Drug: DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Experimental: DU-176b 30 mg
Drug: DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Experimental: DU-176b 60 mg
Drug: DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban
Drug: DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Other Names:
  • edoxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Co., Ltd.

Investigators

  • Principal Investigator: Takeshi Fuji, Director, Osaka Koseinekin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DU176b-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Vein Thrombosis

Clinical Trials on DU-176b

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe