Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)



Status:Active, not recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2012
End Date:September 2016

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A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group,
multi-national, multi-center study of alirocumab (REGN727/SAR236553) in participants with
primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to
statins.


Inclusion:

1. Patients with primary hypercholesterolemia [Heterozygous Familial
Hypercholesterolemia (heFH) or non-FH] with moderate, high or very high CV risk and a
history of statin intolerance

2. Provide signed informed consent

Exclusion:

1. Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening
visit

2. Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the
screening visit

3. A 10-year fatal cardiovascular disease risk score <1% at the screening visit

(The inclusion/ exclusion criteria provided above is not intended to contain all
considerations relevant to a patient's potential participation in this clinical trial).
We found this trial at
42
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Mission Viejo, California 92691
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Newport Beach, California 92660
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Port Matilda, Pennsylvania 16870
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Summerville, South Carolina 29485
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Thousand Oaks, California 91360
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