Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-143 · 6 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 |
| ABT-143 ( rosuvastatin calcium and fenofibric acid ) | DRUG | one dose under low-fat meal condition |
| ABT-143 (rosuvastatin calcium and fenofibric acid ) | DRUG | one dose under fasting meal condition |
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 fixed-dose combination of rosuvastatin calcium and fenofibric acid developed by AstraZeneca PLC (ticker AZN). It is a small molecule product candidate studied for lipid disorders, including dyslipidemia, hypercholesterolemia, and hypertriglyceridemia. It combines a statin with a fenofibric acid component in a single oral dosage form.
ABT-143 was studied for the treatment of dyslipidemia, hypercholesterolemia, and hypertriglyceridemia, conditions involving elevated low density lipoprotein cholesterol and triglycerides. Clinical trials enrolled adults with these lipid abnormalities as well as healthy volunteers in pharmacokinetic studies. It is an investigational combination product and is not described as approved for any indication.
ABT-143 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the clinical program evaluating the combination of rosuvastatin calcium and fenofibric acid, including bioavailability studies and a safety and efficacy study comparing it with simvastatin.
ABT-143 has been studied in Phase 1 and Phase 3 clinical trials, and the program's listed trials are all completed. It is an investigational product candidate and is not described as FDA approved. No active trials are currently listed for ABT-143.
ABT-143 has been evaluated in completed trials including NCT00826358, NCT00812955, NCT00808678, and NCT00728780. These include Phase 1 bioavailability studies in healthy volunteers and a Phase 3 safety and efficacy study comparing ABT-143 with simvastatin in subjects with elevated low density lipoprotein cholesterol and triglycerides.