Open Label Study of Long Term Safety Evaluation of Alirocumab



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:December 17, 2013
End Date:June 30, 2017

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Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

Primary Objective:

To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering
therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had
completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and
LTS11717 (NCT01507831).

Secondary Objectives:

- To evaluate the long-term efficacy of alirocumab on lipid parameters.

- To evaluate the long-term immunogenicity of alirocumab.

The maximum study duration will be 176 weeks per participant.

Inclusion criteria:

Participants with heFH who had completed one of the four parent studies (EFC12492,
R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria:

Significant protocol deviation in the parent study; Any permanent treatment discontinuation
from the parent study.

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
We found this trial at
45
sites
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Golden, CO
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Atlantis, FL
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Biddeford, ME
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Boston, MA
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Bountiful, UT
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Caba,
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chesapeake, VA
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Cincinnati, OH
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Clearwater, FL
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Dallas, TX
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Durham, NC
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Evanston, IL
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Fort Lauderdale, FL
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Fort Worth, TX
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Fountain Valley, California 92708
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Fountain Valley, CA
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Framingham, Massachusetts 01702
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Framingham, MA
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Huntsville, AL
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Iowa City, IA
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Jacksonville, FL
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Kansas City, KS
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Los Angeles, CA
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Marion, OH
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Miami, FL
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Mission Viejo, California 92691
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Mission Viejo, CA
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Morristown, NJ
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New York, NY
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Newport Beach, California 92660
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Oakbrook Terrace, Illinois 60181
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Oakbrook Terrace, IL
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Philadelphia, PA
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Portland, OR
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Poughkeepsie, NY
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Raleigh, NC
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Saint Louis, MO
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Sarasota, FL
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Scranton, PA
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Spokane, WA
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Summerville, South Carolina 29485
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Summerville, SC
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Tempe, AZ
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Washington,
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