Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-143 · 5 trials · 5 indications
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 |
| 1 | EXPERIMENTAL | ABT-143 capsules 20/135 mg |
| 2 | ACTIVE_COMPARATOR | ABT-335 135 mg and rosuvastatin 20 mg |
| A | EXPERIMENTAL | ABT-143 capsules 5/45mg |
| B | ACTIVE_COMPARATOR | ABT-335 45mg and rosuvastatin 5mg |
| 3 | EXPERIMENTAL | ABT-143 capsules 5/45mg |
| 4 | ACTIVE_COMPARATOR | ABT-335 45mg and rosuvastatin 5mg |
| Name | Type | Description |
|---|---|---|
| ABT-143 | DRUG | Once daily for 8 weeks |
| simvastatin | DRUG | Once daily for 8 weeks simvastatin capsules 40 mg |
| ABT-335 | DRUG | once, see arm description for more information |
| rosuvastatin | DRUG | once, see arm description for more detail |
| ABT-335 and rosuvastatin | DRUG | once |
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 being studied for dyslipidemia, hypercholesterolemia, and hypertriglyceridemia. It is a combination product containing fenofibric acid and rosuvastatin, intended to address elevated LDL cholesterol and triglycerides. The drug is in clinical development and has not been approved by the FDA.
ABT-143 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company has conducted clinical trials to evaluate the drug's safety and efficacy in patients with lipid disorders.
ABT-143 is in Phase 1 clinical development. While one Phase 3 trial has been completed, the overall development program is currently in the early stage. The drug remains investigational and has not received regulatory approval for any indication.
ABT-143 has been studied in several completed clinical trials. These include NCT00681395, NCT00728780, and NCT00808678, which are Phase 1 bioavailability studies, and NCT00812955, a Phase 3 safety and efficacy study. All trials have been completed, with no active trials currently ongoing.
ABT-143 is a combination product that contains fenofibric acid and rosuvastatin as its active ingredients. It is designed to deliver both drugs in a single formulation, as opposed to taking them separately. Clinical trials have compared the bioavailability of ABT-143 to co-administered fenofibric acid and rosuvastatin.