Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00616772 | Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood | PHASE3 | COMPLETED | 682 | — | — | Feb 1, 2008 | Sep 1, 2012 | Jul 2, 2018 | 124 | United States |
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
| Arm | Type | Description |
|---|---|---|
| ABT-335 + Atorvastatin | EXPERIMENTAL | ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. |
| Placebo + Atorvastatin | PLACEBO_COMPARATOR | Placebo and atorvastatin (up to 40 mg) once daily for 2 years. |
| Name | Type | Description |
|---|---|---|
| ABT-335 | DRUG | Capsule |
| Placebo | DRUG | Capsule |
| Atorvastatin | OTHER | Capsule |
Inclusion Criteria: * Patients with mixed dyslipidemia * Qualifying cIMT thickness Exclusion Criteria: * Patients with certain chronic or unstable medical conditions. * Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications * Pregnant or lacta...