NCT03694197

Long Term Safety Study of PRALUENT

Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,389 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Heterozygous Familial Hypercholesterolemia
• Non-familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Praluent	Subcutaneous (SC) administration

Timeline

• Start date: 2018-09-28
• Primary completion: 2020-04-08
• Completion: 2020-04-08
• First posted: 2018-10-03
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

123 sites across 6 countries: United States, Bulgaria, Estonia, Russia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study