Calendario›SNY›Alirocumab
Alirocumab
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Ensayo de Sanofi en Hipercolesterolemia.
Más ensayos de: Hipercolesterolemia.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 92
- Centros
- 20
- Fin del objetivo primario
- sep 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2011.
Qué mide
Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis (From Baseline to Week 8 (LOCF)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01288469), actualizada en ago 2015.