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

NCT01730053

CompletedPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Hypercholesterolemia

Interventions: Alirocumab, Rosuvastatin, Ezetimibe, Placebo

Countries: United States, Australia, Canada, France, Germany, Italy, Mexico, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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).

Locations (93)

Chandler, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Beverly Hills, California, United States
Fair Oaks, California, United States
Newport Beach, California, United States
Northridge, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
Milford, Connecticut, United States
Atlantis, Florida, United States
Bradenton, Florida, United States
Clearwater, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Oviedo, Florida, United States
Pinellas Park, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Boise, Idaho, United States
Morton, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
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