A phase III, double blind, randomised, two arms, parallel study to compare the efficacy and safety of a 12-week administration of two fixed-dose combinations (Rosuvastatin 20 mg and Fenofibrate 160 mg versus Pravastatin 40 mg and Fenofibrate 160 mg (Pravafenix®)) in patients with mixed dyslipidaemia.

Dyslipidaemia

Mean percent change from baseline (V2) to week 12 (V4) in Low-Density Lipoprotein (LDL) cholesterol.

Mean percent change from baseline (V2) to week 12 (V4) in non-High-Density Lipoprotein (non-HDL) cholesterol., Mean percent change from baseline (V2) to week 12 (V4) in HDL cholesterol., Mean percent change from baseline (V2) to week 12 (V4) in Triglycerides., Mean percent change from baseline (V2) to week 12 (V4) in Total cholesterol., Mean percent change from baseline (V2) to week 12 (V4) in Apolipoprotein B (ApoB)., Percentage of participants who achieve LDL-C < 55 mg/dL (for very-high risk) or < 70 mg/dL (for high risk)., Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs)., Adverse events of special interest: myopathy, rhabdomyolysis., Absolute Change from baseline in laboratory data., Withdrawal rate

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