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Terminated Phase 4 Interventional Results available

Long Term Safety Study of PRALUENT

ClinicalTrials.gov ID: NCT03694197

Public ClinicalTrials.gov record NCT03694197. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682). The secondary objectives of the study were: * To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) * To evaluate the effect of PRALUENT on other lipid parameters * To evaluate the effect of PRALUENT on gonadal steroid hormones

Study identification

NCT ID
NCT03694197
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
1,389 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 28, 2018 (Actual)
Primary completion
Apr 8, 2020 (Actual)
Completion
Apr 8, 2020 (Actual)
Last update posted
Jun 15, 2021

2018 – 2020

United States locations

U.S. sites
57
U.S. states
23
U.S. cities
53
Facility City State ZIP Site status
Regeneron Research Site Auburn Alabama 36830 —
Regeneron Research Site Mobile Alabama 36608 —
Regeneron Research Site Beverly Hills California 90210 —
Regeneron Research Site Los Gatos California 95032 —
Regeneron Research Site North Hollywood California 91606 —
Regeneron Research Site Port Hueneme California 93041 —
Regeneron Research Site Aurora Colorado 80012 —
Regeneron Research Site Colorado Springs Colorado 80906 —
Regeneron Research Site Lake Worth Florida 33461 —
Regeneron Research Site Miami Springs Florida 33166 —
Regeneron Research Site Champaign Illinois 61822 —
Regeneron Research Site Evansville Indiana 47714 —
Regeneron Research Site Indianapolis Indiana 46237 —
Regeneron Research Site Ames Iowa 50010-30144 —
Regeneron Research Site Iowa City Iowa 52242 —
Regeneron Research Site Waterloo Iowa 50702 —
Regeneron Research Site Newton Kansas 67114 —
Regeneron Research Site Louisville Kentucky 40213 —
Regeneron Research Site Bangor Maine 04401 —
Regeneron Research Site Baltimore Maryland 21229 —
Regeneron Research Site Oxon Hill Maryland 20745 —
Regeneron Research Site Olive Branch Mississippi 38654 —
Regeneron Research Site Washington Missouri 63090 —
Regeneron Research Site Buffalo New York 14215 —
Regeneron Research Site New Hyde Park New York 11042 —
Regeneron Research Site Cary North Carolina 27518 —
Regeneron Research Site Charlotte North Carolina 28209 —
Regeneron Research Site Charlotte North Carolina 28277 —
Regeneron Research Site Greensboro North Carolina 27401 —
Regeneron Research Site Hickory North Carolina 28601 —
Regeneron Research Site Raleigh North Carolina 27609 —
Regeneron Research Site Rocky Mount North Carolina 27804 —
Regeneron Research Site Salisbury North Carolina 28144 —
Regeneron Research Site Statesville North Carolina 28625 —
Regeneron Research Site Wilmington North Carolina 28401 —
Regeneron Research Site Winston-Salem North Carolina 27103 —
Regeneron Research Site Cincinnati Ohio 45219 —
Regeneron Research Site Cleveland Ohio 44122 —
Regeneron Research Site Dayton Ohio 45414 —
Regeneron Research Site Charleston South Carolina 29407 —
Regeneron Research Site Summerville South Carolina 29485 —
Regeneron Research Site Rapid City South Dakota 57701 —
Regeneron Research Site Bristol Tennessee 37620 —
Regeneron Research Site 2 Knoxville Tennessee 37760 —
Regeneron Research Site 3 Knoxville Tennessee 37912 —
Regeneron Research Site Knoxville Tennessee 37938 —
Regeneron Research Site Powell Tennessee 37849 —
Regeneron Research Site Dallas Texas 75231 —
Regeneron Research Site Houston Texas 77027 —
Regeneron Research Site Schertz Texas 78154 —
Regeneron Research Site Shavano Park Texas 78213 —
Regeneron Research Site Shavano Park Texas 78231 —
Regeneron Research Site Falls Church Virginia 22042 —
Regeneron Research Site Winchester Virginia 22601 —
Regeneron Research Site Tacoma Washington 98405 —
Regeneron Research Site Walla Walla Washington 99362 —
Regeneron Research Site Manitowoc Wisconsin 54220 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 66 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03694197, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 15, 2021 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03694197 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →