Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 183
Healthy volunteers: no

Brief 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

Detailed description:
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.

Arms:
arm 1: Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose. arm 2: Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 3: Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 4: Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 5: Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo Q2W for 12-weeks in combination with atorvastatin stable dose. arm 6: Alirocumab 300 mg Q4W and alternating placebo Q2W for 12-weeks in combination with atorvastatin stable dose.

Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Two SC injections in the abdomen only. intervention 2: Two subcutaneous (SC) injections in the abdomen only. intervention 3: Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.

Protocol document: