Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
Completed · Phase 2 · Has a placebo group
Conditions studied: Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
In brief
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
Key facts
- Study ID
- NCT01576484
- Run by
- Regeneron Pharmaceuticals
- People needed
- 58
- Starts
- 2012-02-28
- Expected to finish
- 2016-12-22
- Last updated by the study team
- 2020-08-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Study site — Mission Viejo, California, United States
- Study site — Newport Beach, California, United States
- Study site — Thousand Oaks, California, United States
- Study site — Miami, Florida, United States
- Study site — Port Orange, Florida, United States
- Study site — Kansas City, Kansas, United States
- Study site — Auburn, Maine, United States
- Study site — St Louis, Missouri, United States
- Study site — Durham, North Carolina, United States
- Study site — Cincinnati, Ohio, United States
- Study site — Houston, Texas, United States
- Study site — Chicoutimi, Quebec, Canada
- Study site — Montreal, Quebec, Canada
- Study site — Sainte-Foy, Quebec, Canada
Full record on ClinicalTrials.gov
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