Calendario›REGN›REGN727

REGN727

Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

Ensayo de REGENERON PHARMACEUTICALS, INC. en Hipercolesterolemia.

Más ensayos de: Hipercolesterolemia.

Fase

Fase 1

Estado

Completado

Participantes

72

previstos

Centros

2

Fin del objetivo primario

may 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en jun 2010.

Qué mide

The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01161082), actualizada en ene 2015.