Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab
 (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia
 at high cardiovascular (CV) risk.
Inclusion Criteria:

 1. Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who
 are not adequately controlled with a stable daily dose of rosuvastatin, with or
 without other LMT.

 OR

 2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not
 adequately controlled with a stable daily dose of rosuvastatin before the screening
 visit, with or without other LMT.

 Exclusion Criteria:

 1. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented
 cardiovascular disease (CVD)

 2. LDL-C less than 100 mg/dL at the screening visit in patients without history of
 documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors

 3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)

 4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI),
 unstable angina leading to hospitalization, percutaneous coronary intervention (PCI),
 coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke,
 transient ischemic attack, carotid revascularization, endovascular procedure or
 surgical intervention for peripheral vascular disease

 5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled
 diabetes

 6. Presence of any clinically significant uncontrolled endocrine disease known to
 influence serum lipids or lipoproteins

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