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A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery

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ClinicalTrials.gov Identifier: NCT00398216
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : February 25, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

Condition or disease Intervention/treatment Phase
Thrombosis Hip Replacement Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 903 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement
Study Start Date : May 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adjudicated Incidence of VTE [ Time Frame: end of treatment ]

    Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.

    A subject was judged to have a VTE if one or more of the following criteria were met:

    • Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit
    • Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit
    • Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery.


Secondary Outcome Measures :
  1. Change in Prothrombin Time (PT) From Baseline [ Time Frame: end of treatment ]
    change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery

  2. Change in Activated Partial Thromboplastin Time (aPTT) From Baseline [ Time Frame: end of treatment ]
    change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery

  3. Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events [ Time Frame: 10 days after first dose ]
    adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose



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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
  1. 18 years of age or older; male or female.
  2. Able to provide written informed consent.
  3. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
  4. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.

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): NCT00398216


Locations
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United States, Connecticut
Hartford, Connecticut, United States
United States, Florida
Sarasota, Florida, United States
United States, Texas
Austin, Texas, United States
Canada, Ontario
Ajax, Ontario, Canada
Cambridge, Ontario, Canada
Guelph, Ontario, Canada
Kitchner, Ontario, Canada
Toronto, Ontario, Canada
Denmark
Hellerup, Denmark
Herlev, Denmark
Horsholm, Denmark
Hungary
Gyula, Hungary
Kecskemet, Hungary
Szeged, Hungary
Latvia
Riga, Latvia
Russian Federation
Krasnoyarsk, Russian Federation
Moscow, Russian Federation
Saratov, Russian Federation
St. Petersburg, Russian Federation
Velikij Novgorod, Russian Federation
Volgograd, Russian Federation
Ukraine
Chernivtsy, Ukraine
Dnepropetrovsk, Ukraine
Donetsk, Ukraine
Kharkiv, Ukraine
Kharkov, Ukraine
Kiev, Ukraine
Lutsk, Ukraine
Lviv, Ukraine
Odessa, Ukraine
Sponsors and Collaborators
Daiichi Sankyo, Inc.

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Responsible Party: Anne MacDonald, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00398216     History of Changes
Other Study ID Numbers: DU176b-PRT011
2006-000758-29 ( EudraCT Number )
First Posted: November 10, 2006    Key Record Dates
Results First Posted: February 25, 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.:
Anti-coagulant
hip replacement
hip replacement surgery
unilateral hip replacement surgery
DeepVein Thrombosis
Venous Thromboembolism
pulmonary embolism
Prevention of Blood Clots
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