Open Label Study of Long Term Safety Evaluation of Alirocumab
Public ClinicalTrials.gov record NCT01954394. 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
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01954394
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 986 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
- Dec 17, 2013 (Type not available)
- Primary completion
- Jun 30, 2017 (Actual)
- Completion
- Jun 30, 2017 (Actual)
- Last update posted
- Jul 24, 2018
2013 – 2017
United States locations
- U.S. sites
- 44
- U.S. states
- 23
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840321 | Huntsville | Alabama | 35801 | — |
| Investigational Site Number 840341 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840334 | Bell Gardens | California | 90201 | — |
| Investigational Site Number 840319 | Fountain Valley | California | 92708 | — |
| Investigational Site Number 840336 | Los Angeles | California | 90048 | — |
| Investigational Site Number 840339 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840337 | Newport Beach | California | 92663 | — |
| Investigational Site Number 840306 | Golden | Colorado | 80401 | — |
| Investigational Site Number 840328 | Washington D.C. | District of Columbia | 20037 | — |
| Investigational Site Number 840344 | Atlantis | Florida | 33462 | — |
| Investigational Site Number 840353 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 840318 | Fort Lauderdale | Florida | 33308-4311 | — |
| Investigational Site Number 840327 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840309 | Miami | Florida | 33174 | — |
| Investigational Site Number 840351 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840315 | Evanston | Illinois | 60201 | — |
| Investigational Site Number 840305 | Oakbrook Terrace | Illinois | 60181 | — |
| Investigational Site Number 840333 | Iowa City | Iowa | 52242 | — |
| Investigational Site Number 840329 | Kansas City | Kansas | 66160 | — |
| Investigational Site Number 840345 | Auburn | Maine | 04210 | — |
| Investigational Site Number 840338 | Biddeford | Maine | 04005 | — |
| Investigational Site Number 840322 | Boston | Massachusetts | 02114 | — |
| Investigational Site Number 840346 | Framingham | Massachusetts | 01702 | — |
| Investigational Site Number 840317 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840349 | St Louis | Missouri | 63136 | — |
| Investigational Site Number 840314 | Morristown | New Jersey | 07901 | — |
| Investigational Site Number 840316 | New York | New York | 10032 | — |
| Investigational Site Number 840324 | Poughkeepsie | New York | 12601 | — |
| Investigational Site Number 840303 | Charlotte | North Carolina | 28204 | — |
| Investigational Site Number 840320 | Durham | North Carolina | 27710 | — |
| Investigational Site Number 840348 | Raleigh | North Carolina | 27609 | — |
| Investigational Site Number 840340 | Cincinnati | Ohio | 45227 | — |
| Investigational Site Number 840302 | Marion | Ohio | 43302 | — |
| Investigational Site Number 840330 | Portland | Oregon | 97239 | — |
| Investigational Site Number 840352 | Beaver | Pennsylvania | 15009 | — |
| Investigational Site Number 840308 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 840342 | Scranton | Pennsylvania | 18503 | — |
| Investigational Site Number 840304 | Summerville | South Carolina | 29485 | — |
| Investigational Site Number 840311 | Dallas | Texas | 75216 | — |
| Investigational Site Number 840312 | Dallas | Texas | 75226 | — |
| Investigational Site Number 840301 | Fort Worth | Texas | 76104 | — |
| Investigational Site Number 840343 | Bountiful | Utah | 84010 | — |
| Investigational Site Number 840354 | Chesapeake | Virginia | 23320 | — |
| Investigational Site Number 840350 | Spokane | Washington | 99204 | — |
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 133 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01954394, 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 Jul 24, 2018 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01954394 live on ClinicalTrials.gov.