A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
1 other identifier
interventional
107
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedStudy Start
First participant enrolled
August 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2009
CompletedResults Posted
Study results publicly available
January 12, 2018
CompletedJanuary 12, 2018
January 1, 2018
5 months
August 12, 2008
July 18, 2017
January 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline (Week 0, Visit 2) and Week 4
Secondary Outcomes (2)
Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time
Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)
Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up
Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)
Study Arms (4)
Placebo Group
PLACEBO COMPARATORMatched Placebo
SB480848 40mg Group
EXPERIMENTALSB480848 40mg/day
SB480848 80mg Group
EXPERIMENTALSB480848 80mg/day
SB480848 160mg Group
EXPERIMENTALSB480848 160mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
GSK Investigational Site
Fukuoka, 812-0025, Japan
GSK Investigational Site
Fukuoka, 818-0036, Japan
GSK Investigational Site
Fukuoka, 819-1102, Japan
GSK Investigational Site
Tokyo, 105-0004, Japan
GSK Investigational Site
Tokyo, 154-0024, Japan
GSK Investigational Site
Tokyo, 160-0017, Japan
GSK Investigational Site
Tokyo, 174-0051, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 13, 2008
Study Start
August 26, 2008
Primary Completion
January 16, 2009
Study Completion
January 16, 2009
Last Updated
January 12, 2018
Results First Posted
January 12, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.