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Open Label Study of Long Term Safety Evaluation of Alirocumab
Open Label Study of Long Term Safety Evaluation of Alirocumab

NCT01954394

CompletedPhase 3

Sponsor: Sanofi

Conditions: Hypercholesterolemia

Interventions: Alirocumab, Lipid-Modifying Therapy (LMT)

Countries: United States, Argentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

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

Exclusion criteria:

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.
Locations (177)
  • Huntsville, Alabama, United States
  • Tempe, Arizona, United States
  • Bell Gardens, California, United States
  • Fountain Valley, California, United States
  • Los Angeles, California, United States
  • Mission Viejo, California, United States
  • Newport Beach, California, United States
  • Golden, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Atlantis, Florida, United States
  • Clearwater, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Sarasota, Florida, United States
  • Evanston, Illinois, United States
  • Oakbrook Terrace, Illinois, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Auburn, Maine, United States
  • Biddeford, Maine, United States
  • Boston, Massachusetts, United States
  • Framingham, Massachusetts, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Morristown, New Jersey, United States
  • New York, New York, United States
  • Poughkeepsie, New York, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • + 147 more on CT.gov