Back to resultsStudy of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Primary Purpose
Arthroplasty, Replacement, Hip, Thrombosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DU-176b
Sponsored by
About this trial
This is an interventional prevention trial for Arthroplasty, Replacement, Hip focused on measuring Deep Vein Thrombosis,, Anticoagulant,, Venous thromboembolic
Eligibility Criteria
Inclusion Criteria: Unilateral hip replacement Exclusion Criteria: 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
Sites / Locations
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
15mg BID
30mg QD
30mg BID
60mg QD
60mg BID
120mg QD
Arm Description
15mg edoxaban administered twice daily (BID)
30mg edoxaban administered once daily (QD)
30mg edoxaban administered twice daily (BID)
60mg edoxaban administered once daily (QD)
60mg edoxaban administered twice daily (BID)
120mg edoxaban administered once daily (QD)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change From Baseline for Prothrombin Time (PT) Results
Intent to Treat (ITT) population
Change From Baseline for International Normalized Ratio (INR) Results
Intent to Treat (ITT) population
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
Intent to Treat (ITT) population
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00107900
Brief Title
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
5. Study Description
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.
Detailed Description
The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Hip, Thrombosis
Keywords
Deep Vein Thrombosis,, Anticoagulant,, Venous thromboembolic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
606 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15mg BID
Arm Type
Experimental
Arm Description
15mg edoxaban administered twice daily (BID)
Arm Title
30mg QD
Arm Type
Experimental
Arm Description
30mg edoxaban administered once daily (QD)
Arm Title
30mg BID
Arm Type
Experimental
Arm Description
30mg edoxaban administered twice daily (BID)
Arm Title
60mg QD
Arm Type
Experimental
Arm Description
60mg edoxaban administered once daily (QD)
Arm Title
60mg BID
Arm Type
Experimental
Arm Description
60mg edoxaban administered twice daily (BID)
Arm Title
120mg QD
Arm Type
Experimental
Arm Description
120mg edoxaban administered once daily (QD)
Intervention Type
Drug
Intervention Name(s)
DU-176b
Primary Outcome Measure Information:
Title
Prevention of Venous Thromboembolism (VTE)
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline for Prothrombin Time (PT) Results
Description
Intent to Treat (ITT) population
Time Frame
end of treatment
Title
Change From Baseline for International Normalized Ratio (INR) Results
Description
Intent to Treat (ITT) population
Time Frame
end of treatment
Title
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
Description
Intent to Treat (ITT) population
Time Frame
end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral hip replacement
Exclusion Criteria:
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
Facility Information:
Facility Name
Local Institution
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
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
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
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