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

The duration of study participation depended on the status of the patient at screening:

- For participants receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior
to screening, the study participation was to be approximately 17 weeks including a
screening period of 1 week, a double-blind treatment period of 8 weeks and a follow-up
period of 8 weeks.

- 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 screening, or drug
naive participants, the study participation was to be approximately 23 weeks with a
screening period of 1 week, a run-in treatment period with atorvastatin 10 mg of 6
weeks, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.

Inclusion criteria:

- 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 screening, or drug naive
participants with primary hypercholesterolemia 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 stable dose of atorvastatin
10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein
cholesterol (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) 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.