Back to resultsA Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SB480848 40mg EC Tablet
SB480848 80mg EC Tablet
SB480848 160mg EC Tablet
SB480848 Placebo Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring SB-480848, Dyslipidaemia
Eligibility Criteria
Inclusion criteria:
Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
Exclusion criteria:
Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined as:
A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest
- Planned CABG or planned PCI or planned major non-cardiac surgery within study period
- No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
- Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
- Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo Group
SB480848 40mg Group
SB480848 80mg Group
SB480848 160mg Group
Arm Description
Matched Placebo
SB480848 40mg/day
SB480848 80mg/day
SB480848 160mg/day
Outcomes
Primary Outcome Measures
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value).
Secondary Outcome Measures
Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by [Baseline value]).
Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00734032
Brief Title
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Official Title
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of SB-480848 to Evaluate the Efficacy and Safety -
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 26, 2008 (Actual)
Primary Completion Date
January 16, 2009 (Actual)
Study Completion Date
January 16, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
SB-480848, Dyslipidaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Matched Placebo
Arm Title
SB480848 40mg Group
Arm Type
Experimental
Arm Description
SB480848 40mg/day
Arm Title
SB480848 80mg Group
Arm Type
Experimental
Arm Description
SB480848 80mg/day
Arm Title
SB480848 160mg Group
Arm Type
Experimental
Arm Description
SB480848 160mg/day
Intervention Type
Drug
Intervention Name(s)
SB480848 40mg EC Tablet
Other Intervention Name(s)
Darapladib
Intervention Description
1 tablet once a day
Intervention Type
Drug
Intervention Name(s)
SB480848 80mg EC Tablet
Intervention Description
1 tablet once a day
Intervention Type
Drug
Intervention Name(s)
SB480848 160mg EC Tablet
Intervention Description
1 tablet once a day
Intervention Type
Drug
Intervention Name(s)
SB480848 Placebo Tablet
Intervention Description
1 tablet once a day
Primary Outcome Measure Information:
Title
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
Description
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value).
Time Frame
Baseline (Week 0, Visit 2) and Week 4
Secondary Outcome Measure Information:
Title
Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time
Description
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by [Baseline value]).
Time Frame
Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)
Title
Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up
Description
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value).
Time Frame
Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
Exclusion criteria:
Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined as:
A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest
Planned CABG or planned PCI or planned major non-cardiac surgery within study period
No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
818-0036
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
819-1102
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
105-0004
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
154-0024
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
174-0051
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110118
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
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