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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107900
Recruitment Status : Completed
First Posted : April 12, 2005
Results First Posted : March 2, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Thrombosis Drug: DU-176b Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Change From Baseline for Prothrombin Time (PT) Results [ Time Frame: end of treatment ]
    Intent to Treat (ITT) population

  2. Change From Baseline for International Normalized Ratio (INR) Results [ Time Frame: end of treatment ]
    Intent to Treat (ITT) population

  3. Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results [ Time Frame: end of treatment ]
    Intent to Treat (ITT) population


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107900


Locations
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United States, Georgia
Local Institution
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Daiichi Sankyo, Inc.
More Information
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Responsible Party: Anne MacDonald, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00107900    
Other Study ID Numbers: DU176b-PRT007
First Posted: April 12, 2005    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: February 26, 2019
Last Verified: February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc.:
Deep Vein Thrombosis,
Anticoagulant,
Venous thromboembolic
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants