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Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

NCT01926782

CompletedPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Hypercholesterolemia

Interventions: Placebo (for alirocumab), Alirocumab, Statin

Countries: United States, Bulgaria, Canada, Hungary, Israel, Norway, Slovakia, United Kingdom

To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Men and women \> age 18 or legal age of majority with elevated LDL-C
2. Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk
3. Willing and able to comply with clinic visits and study-related procedures
4. Provided signed informed consent

Exclusion Criteria:

1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
2. Known history of positive test for human immunodeficiency virus (HIV)
3. Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or participants with short life expectancy.
4. Participants considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator felt would restrict or limit the participant's participation for the duration of the study.
5. Certain laboratory findings obtained during the screening period

The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Locations (83)

Chandler, Arizona, United States
Goodyear, Arizona, United States
Carmichael, California, United States
Fresno, California, United States
West Hills, California, United States
Wildomar, California, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Safety Harbor, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Monroe, Louisiana, United States
Auburn, Maine, United States
Methuen, Massachusetts, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Rochester, New York, United States
Farmville, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
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