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SB480848 EC

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |GSK plc|Last Updated: Jan 12, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment107
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00734032A Phase II Clinical Study of SB-480848 in Dyslipidemic PatientsPHASE2 COMPLETED 107Aug 26, 2008Jan 16, 2009Jan 12, 20187 Japan
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
Baseline (Week 0, Visit 2) and Week 4

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 Endpoints
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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo GroupPLACEBO_COMPARATORMatched Placebo
SB480848 40mg GroupEXPERIMENTALSB480848 40mg/day
SB480848 80mg GroupEXPERIMENTALSB480848 80mg/day
SB480848 160mg GroupEXPERIMENTALSB480848 160mg/day
Interventions
NameTypeDescription
SB480848 40mg EC TabletDRUG1 tablet once a day
SB480848 80mg EC TabletDRUG1 tablet once a day
SB480848 160mg EC TabletDRUG1 tablet once a day
SB480848 Placebo TabletDRUG1 tablet once a day
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites7

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: 1. Recent (i.e.,\<6 months prior to screening) CV event and/or vascular procedure defined as: A)ST-e...

Countries:Japan
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