Description: CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.
Fenofibric Acid: Trilipix, Fibricor
| Study Name | |||
|---|---|---|---|
| M05-758 | Cholesterol Lowering | Phase 3 | A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia |
| M05-748 | Cholesterol Lowering | Phase 3 | A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects with Mixed Dyslipidemia |
| M06-884 | Cholesterol Lowering | Phase 3 | A Year 2, Long-Term, Open-Label, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia |
| M10-275 | Cholesterol Lowering | Phase 3 | A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia |
| M05-750 | Cholesterol Lowering | Phase 3 | A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects with Mixed Dyslipidemia |
| M10-158 | Cholesterol Lowering | Phase 3 | Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial |
| M05-749 | Cholesterol Lowering | Phase 3 | A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Simvastatin Combination Therapy to Fenofibric Acid and Simvastatin Monotherapy in Subjects with Mixed Dyslipidemia |