Back to resultsA Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
Primary Purpose
Thrombosis, Hip Replacement
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Sponsored by
About this trial
This is an interventional prevention trial for Thrombosis focused on measuring Anti-coagulant, hip replacement, hip replacement surgery, unilateral hip replacement surgery, DeepVein Thrombosis, Venous Thromboembolism, pulmonary embolism, Prevention of Blood Clots
Eligibility Criteria
- 18 years of age or older; male or female.
- Able to provide written informed consent.
- Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Prothrombin Time (PT) From Baseline
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
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
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
Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events
adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose
Full Information
NCT ID
NCT00398216
First Posted
November 9, 2006
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00398216
Brief Title
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Hip Replacement
Keywords
Anti-coagulant, hip replacement, hip replacement surgery, unilateral hip replacement surgery, DeepVein Thrombosis, Venous Thromboembolism, pulmonary embolism, Prevention of Blood Clots
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
903 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Primary Outcome Measure Information:
Title
Adjudicated Incidence of VTE
Description
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.
Time Frame
end of treatment
Secondary Outcome Measure Information:
Title
Change in Prothrombin Time (PT) From Baseline
Description
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
Time Frame
end of treatment
Title
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
Description
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
Time Frame
end of treatment
Title
Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events
Description
adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose
Time Frame
10 days after first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
18 years of age or older; male or female.
Able to provide written informed consent.
Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
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.
Facility Information:
City
Hartford
State/Province
Connecticut
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Ajax
State/Province
Ontario
Country
Canada
City
Cambridge
State/Province
Ontario
Country
Canada
City
Guelph
State/Province
Ontario
Country
Canada
City
Kitchner
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Hellerup
Country
Denmark
City
Herlev
Country
Denmark
City
Horsholm
Country
Denmark
City
Gyula
Country
Hungary
City
Kecskemet
Country
Hungary
City
Szeged
Country
Hungary
City
Riga
Country
Latvia
City
Krasnoyarsk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Velikij Novgorod
Country
Russian Federation
City
Volgograd
Country
Russian Federation
City
Chernivtsy
Country
Ukraine
City
Dnepropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kharkov
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lutsk
Country
Ukraine
City
Lviv
Country
Ukraine
City
Odessa
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/
Learn more about this trial
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
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