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Also known as SB-480848 (Darapladib)
SB-480848 · 6 trials · 1 indication
hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. Last Observation Carried Forward (LOCF) data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 52 were reported. The levels were analyzed using analysis of co-variance (ANCOVA), with Acute Coronary Syndrome (ACS) status, pooled country and treatment included as covariates.
The ROC grade III/IV strain spots per 10 millimetre (mm) within the ROI on intravascular ultrasound (IVUS) grey scale based palpography were assessed and change from Baseline at end of 52 was reported. Change from Baseline was calculated as the density of spots at the end of study minus the density of spots recorded at Baseline. If either value was considered missing then the change from Baseline value was missing for the participant. Between treatment group comparisons of change from Baseline were analyzed using ANCOVA adjusting for ACS status, pooled country, Baseline value, matched segment length and treatment. Adjusted means and associated standard errors for each treatment group were presented. The baseline value for each participant was defined as the last value prior to the first dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Subjects with ACS and evidence of MN:SB-480848 | EXPERIMENTAL | Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks |
| Subjects with ACS and evidence of MN: placebo | PLACEBO_COMPARATOR | Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks |
| Non-ACS and ACS subjects without evidence of MN: SB-480848 | EXPERIMENTAL | Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks |
| Non-ACS and those ACS subjects without evidence of MN: placebo | PLACEBO_COMPARATOR | Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks |
| Arm 1 | EXPERIMENTAL | SB-480848 |
| Arm 2 | PLACEBO_COMPARATOR | placebo |
| SB-480848 40 mg | EXPERIMENTAL | SB-480848 40 milligrams (mg) once a day (od) for 14 +/- 4 days followed by carotid endarterectomy. SB-480848 40 mg was administered as 2 SB-480848 20 mg tablets plus 2 placebo tablets. |
| SB-480848 80 mg | EXPERIMENTAL | SB-480848 80 mg od for 14 +/- 4 days followed by carotid endarterectomy.SB-480848 80 mg was administered as 4 20 mg SB-480848 tablets. |
| Matching Placebo | PLACEBO_COMPARATOR | Placebo for 14 +/- 4 days followed by carotid endarterectomy. Placebo was administered as 4 placebo tablets. Placebo tablets were identical in appearance to the SB-480848 20 mg tablets. |
| darapladib | EXPERIMENTAL | darapladib |
| Name | Type | Description |
|---|---|---|
| SB-480848 | DRUG | SB-480848 is available as enteric-coated, free-base micronized tablet |
| SB-480848 matching placebo | DRUG | Placebo is available as enteric-coated, free-base micronized tablet |
| placebo | DRUG | placebo |
| SB-480848 40 mg | DRUG | Study Drug |
| SB-480848 80 mg | DRUG | Study Drug |
| SB-480848 (darapladib) | DRUG | 160 mg darapladib |
| SB 480848, tablets | DRUG | - |
Inclusion criteria: * Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization * Suitable non-intervened coronary artery with IVUS * Antiplatelet therapy Exclusion criteria: * Clinical instability * Previous CABG (Coronary Artery By-pass Graft) surgery * Pla...
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SB-480848 is an investigational small molecule being studied for atherosclerosis, a cardiovascular condition involving plaque buildup in the arteries. It has been evaluated in clinical trials in patients with atherosclerosis, including a Phase 2 study of its effect on carotid plaque composition in patients undergoing planned carotid endarterectomy.
SB-480848 is developed by GSK plc, which trades under the ticker GSK. GSK has sponsored the clinical trial program for the drug, including Phase 1 and Phase 2 studies in atherosclerosis and related conditions.
SB-480848 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 program includes a study of its effect on carotid plaque composition in patients with atherosclerosis who are scheduled for carotid endarterectomy.
SB-480848 has been studied in six completed clinical trials, including NCT01916720, a Phase 2 study of carotid plaque composition in patients with planned carotid endarterectomy, and NCT00704431, NCT00622830, and NCT00368576, which were Phase 1 studies. Total enrollment across the program was 1,495 participants.
Yes, SB-480848 is also known as darapladib. Other names used for the same compound include SB 480848 and SB-480848 40 mg, which refers to a tablet dose form. These names all refer to the same investigational small molecule developed by GSK for atherosclerosis.