efficacy and safety evaluation of alirocumab (sar236553/regn727) when co-administered with high dose of atorvastatin in patients with primary hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: primary objective: to evaluate the effect of alirocumab (sar236553/regn727) on low-density lipoprotein cholesterol (ldl-c) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with ldl-c ≥ 100mg/dl (≥ 2.59 mmol/l) on atorvastatin 10 mg. secondary objectives: * to evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * to evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * to evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * 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 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.

Eligibility criteria:
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.

Keywords: 10020603