drugset / Trial / NCT03694197

Long Term Safety Study of PRALUENT

NCT03694197

Phase 4 Terminated 1389 enrolled Regeneron Pharmaceuticals Sanofi · collab
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2018-09-28
Primary completion
2020-04-08
Completion
2020-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Alirocumab Monoclonal antibody Subcutaneous