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)



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:October 2013
End Date:May 2015
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

The purpose of the study is to determine if the study drug (alirocumab)administered every 4
weeks, given by injection under the skin is effective and safe compared with placebo in
lowering cholesterol, if used alone or added to the participants' current
cholesterol-lowering medication.


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. Provide 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 patients with short life expectancy.

4. Patients 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 feels would restrict or limit the patient'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
patient's potential participation in a clinical trial and not all inclusion/ exclusion
criteria are listed.
We found this trial at
50
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Boise, ID
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Carmichael, CA
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Chicago, IL
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Clearwater, FL
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Colorado Springs, Colorado 80910
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Fresno, CA
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Golden, CO
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Goodyear, AZ
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Greenville, North Carolina 27834
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Gurnee, IL
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Haverhill, MA
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Houston, TX
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Kenosha, WI
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Marion, OH
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Philadelphia, PA
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Wilson, NC
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