Stopped: The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.
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
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
Timeframe: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks