Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

February 8, 2019 updated by: Daiichi Sankyo, Inc.

A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Study Type

Interventional

Enrollment (Actual)

606

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

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Local Institution

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral hip replacement

Exclusion Criteria:

  • Patients scheduled for bilateral hip replacement in same procedure
  • Patients with increased risk of bleeding
  • Uncontrolled hypertension (BP greater than 180/100 mmHg)
  • Patients less than 111 lbs or more than 243 lbs
  • Patients on long-term anticoagulants
  • Patients with contraindications to venography
  • Patients with medical history of venous thromboembolism
  • Patients with impaired hepatic function
  • Known to be pregnant
  • Lactating women

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15mg BID
15mg edoxaban administered twice daily (BID)
Drug: DU-176b
Experimental: 30mg QD
30mg edoxaban administered once daily (QD)
Drug: DU-176b
Experimental: 30mg BID
30mg edoxaban administered twice daily (BID)
Drug: DU-176b
Experimental: 60mg QD
60mg edoxaban administered once daily (QD)
Drug: DU-176b
Experimental: 60mg BID
60mg edoxaban administered twice daily (BID)
Drug: DU-176b
Experimental: 120mg QD
120mg edoxaban administered once daily (QD)
Drug: DU-176b

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of Venous Thromboembolism (VTE)
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 (approximately 2 weeks post surgery).

Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline for Prothrombin Time (PT) Results
Time Frame: end of treatment
Intent to Treat (ITT) population
end of treatment
Change From Baseline for International Normalized Ratio (INR) Results
Time Frame: end of treatment
Intent to Treat (ITT) population
end of treatment
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
Time Frame: end of treatment
Intent to Treat (ITT) population
end of treatment

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo, Inc.

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

January 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

April 11, 2005

First Submitted That Met QC Criteria

April 11, 2005

First Posted (Estimate)

April 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DU176b-PRT007

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
  • SAP
  • 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.

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