Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-143 · 1 trial · 1 indication
The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
| Arm | Type | Description |
|---|---|---|
| A - ABT-143 capsules 5/135 mg | EXPERIMENTAL | ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
| B - ABT-143 capsules 10/135 mg | EXPERIMENTAL | ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
| C - ABT-143 capsules 20/135 mg | EXPERIMENTAL | ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
| D - Simvastatin capsules 40 mg | ACTIVE_COMPARATOR | Simvastatin capsules 40 mg daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-143 | DRUG | Once daily for 8 weeks |
| simvastatin | DRUG | Once daily for 8 weeks simvastatin capsules 40 mg |
Inclusion Criteria * Participants with hypercholesterolemia and hypertriglyceridemia. * Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)): * Triglycerides level greater than or equal to 150 millig...
ABT-143 is an investigational small molecule combination therapy being developed by AstraZeneca PLC for dyslipidemia, hypercholesterolemia, and hypertriglyceridemia. It combines rosuvastatin calcium and fenofibric acid and has completed a Phase 3 clinical trial. It is not yet approved for commercial use.
ABT-143 is being developed to treat dyslipidemia, hypercholesterolemia, and hypertriglyceridemia. These conditions involve elevated levels of low density lipoprotein cholesterol and triglycerides. The drug has been studied in a Phase 3 trial but is not yet approved for any indication.
ABT-143 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 3 clinical trial evaluating the combination of rosuvastatin calcium and fenofibric acid.
ABT-143 has completed a Phase 3 clinical trial. The trial, NCT00812955, was a randomized, double-blind, active-controlled study that enrolled 474 participants. The drug remains investigational and is not approved for marketing.
ABT-143 has been evaluated in one completed Phase 3 trial, NCT00812955, titled "Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol and Triglycerides." The trial enrolled 474 participants in the United States and is no longer active.