Open Label Study of Long Term Safety Evaluation of Alirocumab

Completed · Phase 3

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01954394

Run by

Sanofi

People needed

986

Starts

2013-12-17

Expected to finish

2017-06-30

Last updated by the study team

2018-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840341 — Tempe, Arizona, United States
• Investigational Site Number 840334 — Bell Gardens, California, United States
• Investigational Site Number 840319 — Fountain Valley, California, United States
• Investigational Site Number 840336 — Los Angeles, California, United States
• Investigational Site Number 840339 — Mission Viejo, California, United States
• Investigational Site Number 840337 — Newport Beach, California, United States
• Investigational Site Number 840306 — Golden, Colorado, United States
• Investigational Site Number 840328 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840344 — Atlantis, Florida, United States
• Investigational Site Number 840353 — Clearwater, Florida, United States
• Investigational Site Number 840318 — Fort Lauderdale, Florida, United States
• Investigational Site Number 840327 — Jacksonville, Florida, United States
• Investigational Site Number 840309 — Miami, Florida, United States
• Investigational Site Number 840351 — Sarasota, Florida, United States
• Investigational Site Number 840315 — Evanston, Illinois, United States
• Investigational Site Number 840305 — Oakbrook Terrace, Illinois, United States
• Investigational Site Number 840333 — Iowa City, Iowa, United States
• Investigational Site Number 840329 — Kansas City, Kansas, United States
• Investigational Site Number 840345 — Auburn, Maine, United States
• Investigational Site Number 840338 — Biddeford, Maine, United States
• Investigational Site Number 840322 — Boston, Massachusetts, United States
• Investigational Site Number 840346 — Framingham, Massachusetts, United States
• Investigational Site Number 840317 — St Louis, Missouri, United States
• Investigational Site Number 840349 — St Louis, Missouri, United States
• Investigational Site Number 840321 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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