| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00734032 | A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients | PHASE2 | COMPLETED | 107 | — | — | Aug 26, 2008 | Jan 16, 2009 | Jan 12, 2018 | 7 | Japan |
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...