Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
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
1 other identifier
interventional
606
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2005
Shorter than P25 for phase_2
1 active site
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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 11, 2005
CompletedFirst Posted
Study publicly available on registry
April 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
March 2, 2015
CompletedFebruary 26, 2019
February 1, 2015
11 months
April 11, 2005
February 5, 2015
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of Venous Thromboembolism (VTE)
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
2 weeks
Secondary Outcomes (3)
Change From Baseline for Prothrombin Time (PT) Results
end of treatment
Change From Baseline for International Normalized Ratio (INR) Results
end of treatment
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
end of treatment
Study Arms (6)
15mg BID
EXPERIMENTAL15mg edoxaban administered twice daily (BID)
30mg QD
EXPERIMENTAL30mg edoxaban administered once daily (QD)
30mg BID
EXPERIMENTAL30mg edoxaban administered twice daily (BID)
60mg QD
EXPERIMENTAL60mg edoxaban administered once daily (QD)
60mg BID
EXPERIMENTAL60mg edoxaban administered twice daily (BID)
120mg QD
EXPERIMENTAL120mg edoxaban administered once daily (QD)
Interventions
Eligibility Criteria
You may qualify if:
- Unilateral hip replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (1)
Local Institution
Decatur, Georgia, 30033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Victor Fernandez
- 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 11, 2005
First Posted
April 12, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
February 26, 2019
Results First Posted
March 2, 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/