Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Exclusion Criteria

• •Age \<18 or legal age of adulthood, whichever was greater
• •Participants without established CHD or CHD risk equivalent
• •LDL-C \<70 mg/dL (\<1.81 mmol/L) and participants with a history of documented cardiovascular disease
• •LDL-C \<100 mg/dL (\<2.59 mmol/L) and participants without a history of documented cardiovascular disease
• •Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization
• •Fasting serum triglycerides \> 400 mg/dL (\>4.52 mmol/L)
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.