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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01709513

Run by

Regeneron Pharmaceuticals

People needed

314

Starts

2012-09-30

Expected to finish

2017-05-31

Last updated by the study team

2020-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Newport Beach, California, United States
• Study site — Northridge, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Trinity, Florida, United States
• Study site — Addison, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Auburn, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Clifton, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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