Long Term Safety Study of PRALUENT
Stopped early · Phase 4
Conditions studied: Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
In brief
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682). The secondary objectives of the study were: * To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) * To evaluate the effect of PRALUENT on other lipid parameters * To evaluate the effect of PRALUENT on gonadal steroid hormones
Key facts
- Study ID
- NCT03694197
- Run by
- Regeneron Pharmaceuticals
- People needed
- 1389
- Starts
- 2018-09-28
- Expected to finish
- 2020-04-08
- Last updated by the study team
- 2021-06-15
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Regeneron Research Site — Mobile, Alabama, United States
- Regeneron Research Site — Beverly Hills, California, United States
- Regeneron Research Site — Los Gatos, California, United States
- Regeneron Research Site — North Hollywood, California, United States
- Regeneron Research Site — Port Hueneme, California, United States
- Regeneron Research Site — Aurora, Colorado, United States
- Regeneron Research Site — Colorado Springs, Colorado, United States
- Regeneron Research Site — Lake Worth, Florida, United States
- Regeneron Research Site — Miami Springs, Florida, United States
- Regeneron Research Site — Champaign, Illinois, United States
- Regeneron Research Site — Evansville, Indiana, United States
- Regeneron Research Site — Indianapolis, Indiana, United States
- Regeneron Research Site — Ames, Iowa, United States
- Regeneron Research Site — Iowa City, Iowa, United States
- Regeneron Research Site — Waterloo, Iowa, United States
- Regeneron Research Site — Newton, Kansas, United States
- Regeneron Research Site — Louisville, Kentucky, United States
- Regeneron Research Site — Bangor, Maine, United States
- Regeneron Research Site — Baltimore, Maryland, United States
- Regeneron Research Site — Oxon Hill, Maryland, United States
- Regeneron Research Site — Olive Branch, Mississippi, United States
- Regeneron Research Site — Washington, Missouri, United States
- Regeneron Research Site — Buffalo, New York, United States
- Regeneron Research Site — New Hyde Park, New York, United States
- Regeneron Research Site — Auburn, Alabama, United States
Full record on ClinicalTrials.gov
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