A Study of DU-176b in Preventing Blood Clots After Hip Re... | NCT00398216 | Trialant
NCT00398216
Sponsor
Daiichi Sankyo
Status
Completed
Last Update Posted
Feb 26, 2019Actual
Enrollment
903Actual
Phase
Phase 2
Conditions
Thrombosis
Hip Replacement
Interventions
DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Countries
United States
Canada
Denmark
Hungary
Latvia
Russia
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00398216
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DU176b-PRT011
Secondary IDs
ID
Type
Description
Link
2006-000758-29
EudraCT Number
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
Acronym
Not provided
Organization
Daiichi SankyoINDUSTRY
Status Module
Record Verification Date
Feb 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2006
Primary Completion Date
Jun 2007Actual
Completion Date
Jun 2007Actual
First Submitted Date
Nov 9, 2006
First Submission Date that Met QC Criteria
Nov 9, 2006
First Posted Date
Nov 10, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 5, 2015
Results First Submitted that Met QC Criteria
Feb 5, 2015
Results First Posted Date
Feb 25, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 8, 2019
Last Update Posted Date
Feb 26, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Daiichi SankyoINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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
Conditions Module
Conditions
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
903Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Drug
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
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
end of treatment
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Hartford
Connecticut
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
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/
Types
Study Protocol
Statistical Analysis Plan (SAP)
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.
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
end of treatment
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
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
FG000192 subjects
FG001170 subjects
FG002185 subjects
FG003177 subjects
FG004172 subjects
COMPLETED
FG000181 subjects
FG001151 subjects
FG002164 subjects
FG003155 subjects
FG004157 subjects
NOT COMPLETED
FG00011 subjects
FG00119 subjects
FG00221 subjects
FG00322 subjects
FG00415 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0012 subjects
FG0025 subjects
FG0037 subjects
FG0042 subjects
Protocol Violation
FG0002 subjects
FG0014 subjects
FG0025 subjects
FG0037 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0016 subjects
FG0024 subjects
FG0034 subjects
FG004
Death
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
administrative reasons
FG0003 subjects
FG0014 subjects
FG0024 subjects
FG0033 subjects
FG004
entrance criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Edoxaban 15mg QD
edoxaban 15mg QD (once daily) orally (PO)
BG001
Edoxaban 30mg QD
edoxaban 30mg QD PO
BG002
Edoxaban 60mg QD
edoxaban 60mg QD PO
BG003
Edoxaban 90mg QD
edoxaban 90mg QD PO
BG004
Dalteparin
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000192
BG001170
BG002185
BG003177
BG004172
BG005896
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.3± 12.49
BG00157.2± 12.28
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000113
BG001111
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
North America
Title
Measurements
BG00033
BG00120
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
per protocol analysis set
Posted
Number
95% Confidence Interval
percentage of participants with VTE
end of treatment
ID
Title
Description
OG000
Edoxaban 15mg QD
edoxaban 15mg QD (once daily) orally (PO)
OG001
Edoxaban 30mg QD
edoxaban 30mg QD PO
OG002
Edoxaban 60mg QD
edoxaban 60mg QD PO
OG003
Edoxaban 90mg QD
edoxaban 90mg QD PO
OG004
Dalteparin
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
Units
Counts
Participants
OG000162
OG001143
OG002153
OG003
Title
Denominators
Categories
Title
Measurements
OG00029.0(22.2 to 36.7)
OG00120.3(14.0 to 27.8)
OG00215.7(10.3 to 22.4)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Fisher Exact
0.003
2-Sided
Superiority or Other
OG001
OG004
Fisher Exact
<0.001
Secondary
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
perp protocol analysis set
Posted
Mean
Standard Deviation
seconds
end of treatment
ID
Title
Description
OG000
Edoxaban 15mg QD
edoxaban 15mg QD (once daily) orally (PO)
OG001
Edoxaban 30mg QD
edoxaban 30mg QD PO
OG002
Edoxaban 60mg QD
edoxaban 60mg QD PO
OG003
Edoxaban 90mg QD
edoxaban 90mg QD PO
OG004
Dalteparin
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
Secondary
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
perp protocol analysis set
Posted
Mean
Standard Deviation
seconds
end of treatment
ID
Title
Description
OG000
Edoxaban 15mg QD
edoxaban 15mg QD (once daily) orally (PO)
OG001
Edoxaban 30mg QD
edoxaban 30mg QD PO
OG002
Edoxaban 60mg QD
edoxaban 60mg QD PO
OG003
Edoxaban 90mg QD
edoxaban 90mg QD PO
OG004
Dalteparin
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
Secondary
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
safety analysis dataset
Posted
Number
95% Confidence Interval
percentage of subjects with bleed events
10 days after first dose
ID
Title
Description
OG000
Edoxaban 15mg QD
edoxaban 15mg QD (once daily) orally (PO)
OG001
Edoxaban 30mg QD
edoxaban 30mg QD PO
OG002
Edoxaban 60mg QD
edoxaban 60mg QD PO
OG003
Edoxaban 90mg QD
edoxaban 90mg QD PO
OG004
Dalteparin
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Edoxaban 15mg QD
edoxaban 15mg QD (once daily) orally (PO)
8
192
30
192
EG001
Edoxaban 30mg QD
edoxaban 30mg QD PO
6
170
16
170
EG002
Edoxaban 60mg QD
edoxaban 60mg QD PO
8
185
22
185
EG003
Edoxaban 90mg QD
edoxaban 90mg QD PO
10
177
25
177
EG004
Dalteparin
dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
3
172
22
172
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG0031 events1 affected177 at risk
EG0040 events0 affected172 at risk
angina pectoris
Cardiac disorders
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
cardiopulmonary failure
Cardiac disorders
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
myocardial infarction
Cardiac disorders
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0011 events1 affected170 at risk
EG0020 events0 affected185 at risk
EG003
myocardial ischemia
Cardiac disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected170 at risk
EG0020 events0 affected185 at risk
EG003
supraventricular tachycardia
Cardiac disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
death
General disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected170 at risk
EG0020 events0 affected185 at risk
EG003
secretion of discharge
General disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
anaphylactic reaction
Immune system disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
drug hypersensitivity
Immune system disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
gastroenteritis
Infections and infestations
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
paronychia
Infections and infestations
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
dislocation of joint prosthesis
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected170 at risk
EG0021 events1 affected185 at risk
EG003
fat embolism
Injury, poisoning and procedural complications
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
hip fracture
Injury, poisoning and procedural complications
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0021 events1 affected185 at risk
EG003
incision site hematoma
Injury, poisoning and procedural complications
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0021 events1 affected185 at risk
EG003
post-procedural complication
Injury, poisoning and procedural complications
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
hepatic enzyme increased
Investigations
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
syncope
Nervous system disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0021 events1 affected185 at risk
EG003
transient ischemic attack
Nervous system disorders
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0022 events2 affected185 at risk
EG003
cardiovascular insufficiency
Vascular disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0011 events1 affected170 at risk
EG0020 events0 affected185 at risk
EG003
deep vein thrombosis
Vascular disorders
MedDRA (9.0)
Systematic Assessment
EG0002 events2 affected192 at risk
EG0011 events1 affected170 at risk
EG0022 events2 affected185 at risk
EG003
hematoma
Vascular disorders
MedDRA (9.0)
Systematic Assessment
EG0001 events1 affected192 at risk
EG0010 events0 affected170 at risk
EG0021 events1 affected185 at risk
EG003
wound hemorrhage
Vascular disorders
MedDRA (9.0)
Systematic Assessment
EG0000 events0 affected192 at risk
EG0010 events0 affected170 at risk
EG0020 events0 affected185 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
constipation
Gastrointestinal disorders
MedDRA (9.0)
Systematic Assessment
EG0005 affected192 at risk
EG0013 affected170 at risk
EG0028 affected185 at risk
EG00314 affected177 at risk
EG0046 affected172 at risk
nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00013 affected192 at risk
EG0014 affected170 at risk
EG0028 affected185 at risk
EG003
edema peripheral
General disorders
MedDRA (9.0)
Systematic Assessment
EG00011 affected192 at risk
EG0015 affected170 at risk
EG0027 affected185 at risk
EG003
pyrexia
General disorders
MedDRA (9.0)
Systematic Assessment
EG00015 affected192 at risk
EG0013 affected170 at risk
EG0028 affected185 at risk
EG003
procedural pain
Injury, poisoning and procedural complications
MedDRA (9.0)
Systematic Assessment
EG00010 affected192 at risk
EG0015 affected170 at risk
EG0028 affected185 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.