A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
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
2 other identifiers
interventional
903
7 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
November 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedResults Posted
Study results publicly available
February 25, 2015
CompletedFebruary 26, 2019
February 1, 2015
1.1 years
November 9, 2006
February 5, 2015
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjudicated Incidence of VTE
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.
end of treatment
Secondary Outcomes (3)
Change in Prothrombin Time (PT) From Baseline
end of treatment
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
end of treatment
Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events
10 days after first dose
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (29)
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Ajax, Ontario, Canada
Unknown Facility
Cambridge, Ontario, Canada
Unknown Facility
Guelph, Ontario, Canada
Unknown Facility
Kitchner, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Hellerup, Denmark
Unknown Facility
Herlev, Denmark
Unknown Facility
Hørsholm, Denmark
Unknown Facility
Gyula, Hungary
Unknown Facility
Kecskemét, Hungary
Unknown Facility
Szeged, Hungary
Unknown Facility
Riga, Latvia
Unknown Facility
Krasnoyarsk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Veliky Novgorod, Russia
Unknown Facility
Volgograd, Russia
Unknown Facility
Chernivtsy, Ukraine
Unknown Facility
Dnipro, Ukraine
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Lutsk, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Odesa, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- William Maxwell, Assoc. Director
- Organization
- Daiichi Sankyo, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2006
First Posted
November 10, 2006
Study Start
May 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
February 26, 2019
Results First Posted
February 25, 2015
Record last verified: 2015-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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/