Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

Key facts

Study ID

NCT01730040

Run by

Regeneron Pharmaceuticals

People needed

355

Starts

2012-10-01

Expected to finish

2014-05-01

Last updated by the study team

2015-08-31

Who can join

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

You may qualify if…

• Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
• Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.

You may not qualify if…

• LDL-C greater than 250 mg/dL
• LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
• LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
• TG greater than 400 mg/dL
• Homozygous FH (clinically or previous genotyping)
• Currently taking a statin that is not atorvastatin
• Currently taking Ezetimibe (EZE)
• Not on a stable dose of allowable lipid modifying treatments (LMT)
• (The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Lakeland Village, California, United States
• Study site — Newport Beach, California, United States
• Study site — Northridge, California, United States
• Study site — Sacramento, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Milford, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Boca Raton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami (2 Locations), Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.