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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)

NCT01709513

CompletedPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Hypercholesterolemia

Interventions: Atorvastatin, Ezetimibe, Alirocumab, Placebo

Countries: United States, Austria, Canada, France, Israel, Italy, Norway, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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).
Locations (70)
  • Anaheim, California, United States
  • Beverly Hills, California, United States
  • Mission Viejo, California, United States
  • Newport Beach, California, United States
  • Northridge, California, United States
  • Thousand Oaks, California, United States
  • Hartford, Connecticut, United States
  • Boynton Beach, Florida, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Pembroke Pines, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Trinity, Florida, United States
  • Addison, Illinois, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Kansas City, Kansas, United States
  • Auburn, Maine, United States
  • Boston, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Clifton, New Jersey, United States
  • New York, New York, United States
  • Poughkeepsie, New York, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Marion, Ohio, United States
  • Danville, Pennsylvania, United States
  • + 40 more on CT.gov