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alirocumab

Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

Ensayo de Sanofi en Hipercolesterolemia.

Más ensayos de: Hipercolesterolemia.

Fase

Fase 1

Estado

Completado

Participantes

20

previstos

Centros

1

Fin del objetivo primario

may 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, simple ciego. Comenzó en dic 2013.

Qué mide

Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment (baseline and at 12 days after last dose of alirocumab) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C). Secondary Objectives: To assess the effects of SC doses of alirocumab on: * Various parameters of the metabolism and turnover in plasma of different lipoproteins * Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a)) * Lipoprotein particle size profile * PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01959971), actualizada en abr 2017.