Calendario›REGN›ALIROCUMAB SAR236553

ALIROCUMAB SAR236553

Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

Ensayo de REGENERON PHARMACEUTICALS, INC. en Hipercolesterolemia.

Más ensayos de: Hipercolesterolemia.

Fase

no aplica

Estado

Interrumpido

Participantes

37

previstos

Centros

1

Fin del objetivo primario

sep 2020

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en dic 2017.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «(due to change in the post-marketing requirement to assess alirocumab during pregnancy)».

Qué mide

Rate of major structural birth defects (Up to 1 year of age of the infant) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison pregnancies. Secondary Objectives: * Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and non-diseased comparison pregnancies, and secondarily to compare the rates of these outcomes in the unexposed disease-matched pregnancies to the rates in the unexposed non-diseased comparison pregnancies. * Safety and tolerability of alirocumab.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03379558), actualizada en nov 2020.