Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Inclusion criteria: * Participants with primary hypercholesterolemia receiving a lipid-lowering treatment other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period or drug naive participants if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy OR * Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period and likely to have LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit Exclusion criteria: 1. LDL-C \< 100 mg/dL (\< 2.59 mmol/L): * After the run-in period on atorvastatin (10 mg, 20 mg, or 40 mg) for participants receiving a lipid-lowering treatment other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to the screening, or drug naive participant OR * At the first visit for participants who were being treated with stable dose of atorvastatin (10 mg, 20 mg, or 40 mg) for at least 6 weeks prior to screening 2. Participants not previously instructed on a cholesterol-lowering diet 3. Participants with type 1 diabetes 4. Participants with type 2 diabetes treated with insulin 5. Participants with type 2 diabetes and with an glycated hemoglobin (HbA1c) ≥ 8.5% at screening visit (considered poorly controlled) 6. Laboratory findings measured before randomization: * Triglycerides (TG) \> 350 mg/dL (\> 3.95 mmol/L) at screening visit * Positive serum or urine pregnancy test in females of childbearing potential 7. Pregnant or breast-feeding women 8. Women of childbearing potential with no effective contraceptive method The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.