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

Sanofi · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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hypercholesterolemia
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
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