Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01730053

Run by

Regeneron Pharmaceuticals

People needed

305

Starts

2012-11-30

Expected to finish

2014-05-31

Last updated by the study team

2020-04-07

Who can join

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

You may qualify if…

• 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
• 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.

You may not qualify if…

• LDL-C less than 70 mg/dL at the screening visit in patients with history of documented cardiovascular disease (CVD)
• 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
• Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)
• 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
• Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled diabetes
• 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).

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Fair Oaks, 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 — Bradenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lakeland, Florida, United States
• (2 Locations) — Miami, 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 — Winter Park, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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