Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group,
 multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe
 in participants with primary hypercholesterolemia and moderate, high, or very high CV risk,
 who are intolerant to statins. An atorvastatin arm is added to determine that the population
 selected in the study is a truly statin intolerant population by assessing skeletal
 muscle-related adverse events.
Inclusion:

 1. Patients with primary hypercholesterolemia [Heterozygous Familial Hypercholesterolemia
 (heFH) or non-FH] with moderate, high or very high CV risk and a history of statin
 intolerance

 2. Provide signed informed consent

 Exclusion:

 1. Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening
 visit

 2. Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the
 screening visit

 3. A 10-year fatal cardiovascular disease risk score <1% at the screening visit

 (The inclusion/ exclusion criteria provided above is not intended to contain all
 considerations relevant to a patient's potential participation in this clinical trial).