efficacy and safety evaluation of alirocumab (sar236553/regn727) in patients with primary hypercholesterolemia on stable atorvastatin therapy

Conditions: Hypercholesterolemia

Summary: 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.

Eligibility criteria:
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.