Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2012
End Date:November 2014

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Trial Summary
Trial Overview
Inclusion Criteria

Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
(proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk
participants with hypercholesterolemia not adequately controlled with their current lipid
modifying therapy (LMT).

Secondary Objectives:

- To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)
levels after 24 weeks of treatment in comparison with placebo.

- To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
points.

- To evaluate the effects of alirocumab on other lipid parameters.

The maximum study duration was to be 89 weeks per participant, including a 3-week screening
period, a 78-week randomized treatment period and 8-week follow-up period.

Inclusion criteria:

Either A or B below and who were not adequately controlled with their lipid-modifying
therapy:

A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without
established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Participants with hypercholesterolemia together with established CHD or CHD risk
equivalents.

Exclusion criteria:

- Age < 18 years

- LDL-C <70 mg/dL (< 1.81 mmol/L)

- Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

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
96
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Bronxville, New York 10708
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Brooklyn, New York 11215
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Camp Hill, Pennsylvania 17011
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Charleston, South Carolina 29412
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Clinical Trial Facility in Charlotte North Carolina
Charlotte, North Carolina 28207
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Chesapeake, Virginia 23320
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Clearwater, Florida 33756
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Colorado Springs, Colorado 80910
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Crystal River, Florida 34429
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Cumming, Georgia 30041
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Clinical Trial Facility in Dayton Ohio
Dayton, Ohio 45409
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Daytona Beach, Florida 32117
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Clinical Trial Facility in Duncansville Pennsylvania
Duncansville, Pennsylvania 16635
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Clinical Trial Facility in Edison New Jersey
Edison, New Jersey 08817
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Clinical Trial Facility in Evansville Indiana
Evansville, Indiana 47713
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Fleming Island, Florida 32003
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Fresno, California 93706
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Ft. Lauderdale, Florida 33308
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Gilbert, Arizona 85234
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Greensboro, North Carolina 27401
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Greenville, South Carolina 29605
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Guilford, Connecticut 06437
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Hartford, Connecticut 06106
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Jersey Shore, Pennsylvania 17740
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Knoxville, Tennessee 37920
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Pembroke Pines, Florida 33028
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Phoenixville, Pennsylvania 19460
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Clinical Trial Facility in Plano Texas
Plano, Texas 75024
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Poughkeepsie, New York 12601
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Raleigh, North Carolina 27607
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Saginaw, Michigan 48604
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Saint Louis, Missouri 63110
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Santa Rosa, California 95405
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Sarasota, Florida 34239
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Sierra Vista, Arizona 85635
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Tucson, Arizona 85724
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Tyler, Texas 75702
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Varnville, South Carolina 29944
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Wichita, Kansas 67214
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Wyomissing, Pennsylvania 19610
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