Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-335 · 1 trial · 3 indications
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...
ABT-335 is an investigational small molecule being studied for the treatment of Coronary Artery Disease, Coronary Heart Disease, and Dyslipidemia. It is being developed by AbbVie Inc. (ABBV) and is currently in Phase 3 clinical development.
The molecular target of ABT-335 has not been disclosed. It is a small molecule being studied for its effects on thickening of the blood vessel wall in patients with abnormal lipid levels, but its specific mechanism of action is not publicly detailed.
ABT-335 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 3 clinical development for cardiovascular indications.
ABT-335 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in active clinical trials.
ABT-335 has one completed Phase 3 clinical trial, NCT00616772, which studied the drug in combination with atorvastatin in patients with abnormal lipid levels. The trial enrolled 682 participants in the United States and was randomized, double-blind, and placebo-controlled.
ABT-335 is also known as fenofibric acid, a lipid-lowering agent. In clinical trials, it has been studied in combination with atorvastatin to evaluate its effects on blood vessel wall thickening in patients with dyslipidemia and coronary artery disease.