Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Public ClinicalTrials.gov record NCT01623115. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: * 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 * To evaluate the safety and tolerability of alirocumab
Study identification
- NCT ID
- NCT01623115
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 486 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 30, 2012
- Primary completion
- Mar 31, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Feb 7, 2016
2012 – 2014
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840417 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840429 | Long Beach | California | 90801 | — |
| Investigational Site Number 840419 | Los Angeles | California | 90048 | — |
| Investigational Site Number 840421 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840412 | Newport Beach | California | 92660 | — |
| Investigational Site Number 840428 | Newport Beach | California | — | — |
| Investigational Site Number 840461 | Northridge | California | 91324 | — |
| Investigational Site Number 840452 | Washington D.C. | District of Columbia | 20037 | — |
| Investigational Site Number 840456 | Miami | Florida | 33165 | — |
| Investigational Site Number 840418 | Ponte Vedra | Florida | 32081 | — |
| Investigational Site Number 840455 | Evanston | Illinois | 60201 | — |
| Investigational Site Number 840415 | Kansas City | Kansas | 66160-7321 | — |
| Investigational Site Number 840425 | Auburn | Maine | 04210 | — |
| Investigational Site Number 840411 | Boston | Massachusetts | 02114 | — |
| Investigational Site Number 840409 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840407 | Morristown | New Jersey | 07962 | — |
| Investigational Site Number 840408 | New York | New York | 10032 | — |
| Investigational Site Number 840401 | Charlotte | North Carolina | 28207 | — |
| Investigational Site Number 840410 | Durham | North Carolina | 27710 | — |
| Investigational Site Number 840430 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840424 | Portland | Oregon | 97201-3098 | — |
| Investigational Site Number 840404 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840426 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840406 | Nashville | Tennessee | 37232 | — |
| Investigational Site Number 840460 | Dallas | Texas | 75216 | — |
| Investigational Site Number 840422 | Bountiful | Utah | 84010 | — |
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 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01623115, 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 Feb 7, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01623115 live on ClinicalTrials.gov.