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

 -  To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein
 cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in
 participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin
 therapy.

 Secondary Objectives:

 -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment
 in comparison with placebo

 -  To evaluate the safety and tolerability of alirocumab

 -  To evaluate the development of anti-alirocumab antibodies

 -  To evaluate the pharmacokinetics of alirocumab
The duration of study participation depended on the status of the participant at screening:

 -  For participants receiving atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose for at
 least 6 weeks prior to screening, the study participation was to be approximately 21
 weeks including a screening period of 1 week, a double-blind treatment period of 12
 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, 20 mg, or 40 mg for at least 6 weeks prior to
 screening, or drug naive participants, the study participation was to be approximately
 27 weeks including a screening period of 1 week, a run-in treatment period with
 atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose of 6 weeks, a double-blind
 treatment period of 12 weeks, and a follow-up period of 8 weeks.
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.