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

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: 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.

Tracking Information
First Submitted Date  ICMJE November 9, 2006
First Posted Date  ICMJE November 10, 2006
Results First Submitted Date  ICMJE February 5, 2015
Results First Posted Date  ICMJE February 25, 2015
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE May 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2006)
The primary objective of this study is to assess the efficacy of DU-176b in the prevention of VTE.
Change History Complete list of historical versions of study NCT00398216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2006)
The secondary objectives are to compare the incidence of VTE and major and clinically relevant non-major bleeds of DU-176b to dalteparin and to assess the PK and PD properties of DU-176b.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Thrombosis
  • Hip Replacement
Intervention  ICMJE Drug: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2010)
903
Original Enrollment  ICMJE
 (submitted: November 9, 2006)
950
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Hungary,   Latvia,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00398216
Other Study ID Numbers  ICMJE DU176b-PRT011
2006-000758-29 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Anne MacDonald, Daiichi Sankyo
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP