Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

Exclusion Criteria

• •1. LDL-C \< 100 mg/dL (\< 2.59 mmol/L) at Week -1 (V1):
• •* After the run-in period on atorvastatin 10 mg for participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to the screening period, or drug naive participants.
• •OR
• •* At the first visit for participants who are being treated with atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening visit.
• •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 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.