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Long Term Safety Study of PRALUENT
Long Term Safety Study of PRALUENT

NCT03694197

TerminatedPhase 4

Sponsor: Regeneron Pharmaceuticals

Conditions: Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia

Interventions: Praluent

Countries: United States, Bulgaria, Estonia, Russia, South Africa, Ukraine

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

Eligibility overview

Sex: ALL

Age: 40 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Key Exclusion Criteria:

1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
4. Known hypersensitivity to monoclonal antibody or any component of the drug product
5. Pregnant or breastfeeding women

Note: Other inclusion/ exclusion criteria apply
Locations (123)
  • Auburn, Alabama, United States
  • Mobile, Alabama, United States
  • Beverly Hills, California, United States
  • Los Gatos, California, United States
  • North Hollywood, California, United States
  • Port Hueneme, California, United States
  • Aurora, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Lake Worth, Florida, United States
  • Miami Springs, Florida, United States
  • Champaign, Illinois, United States
  • Evansville, Indiana, United States
  • Indianapolis, Indiana, United States
  • Ames, Iowa, United States
  • Iowa City, Iowa, United States
  • Waterloo, Iowa, United States
  • Newton, Kansas, United States
  • Louisville, Kentucky, United States
  • Bangor, Maine, United States
  • Baltimore, Maryland, United States
  • Oxon Hill, Maryland, United States
  • Olive Branch, Mississippi, United States
  • Washington, Missouri, United States
  • Buffalo, New York, United States
  • New Hyde Park, New York, United States
  • Cary, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Hickory, North Carolina, United States
  • + 93 more on CT.gov