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 |
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.
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
sites
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