Calendario›SNY›Alirocumab
Alirocumab
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Ensayo de Sanofi en Hipercolesterolemia.
Más ensayos de: Hipercolesterolemia.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 216
- Centros
- 32
- Fin del objetivo primario
- ene 2015
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2014.
Qué mide
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) (From Baseline to Week 24) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. * To evaluate the effect of alirocumab on other lipid parameters. * To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment. * To evaluate the safety and tolerability of alirocumab. * 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 (NCT02107898), actualizada en sep 2016.