Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB480848 EC · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Placebo Group | PLACEBO_COMPARATOR | Matched Placebo |
| SB480848 40mg Group | EXPERIMENTAL | SB480848 40mg/day |
| SB480848 80mg Group | EXPERIMENTAL | SB480848 80mg/day |
| SB480848 160mg Group | EXPERIMENTAL | SB480848 160mg/day |
| Name | Type | Description |
|---|---|---|
| SB480848 40mg EC Tablet | DRUG | 1 tablet once a day |
| SB480848 80mg EC Tablet | DRUG | 1 tablet once a day |
| SB480848 160mg EC Tablet | DRUG | 1 tablet once a day |
| SB480848 Placebo Tablet | DRUG | 1 tablet once a day |
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...
SB480848 EC is an investigational small molecule being developed for atherosclerosis, a cardiovascular condition characterized by the buildup of plaque in the arteries. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
SB480848 EC is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with atherosclerosis.
SB480848 EC is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for the treatment of atherosclerosis, and its clinical program includes a completed Phase 2 trial.
SB480848 EC has one completed clinical trial, identified as NCT00734032, titled "A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients." This Phase 2 trial enrolled 107 participants in Japan and was a randomized, double-blind, placebo-controlled study involving patients with atherosclerosis.
Yes, SB480848 EC is the same drug as SB-480848. The clinical trial record for the drug uses the name SB-480848, while the drug is also referred to as SB480848 EC. Both names refer to the same investigational compound being developed by GSK plc.