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Irbesartan · COSIMA2
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
Ensayo de Sanofi en Hipertension.
Más ensayos de: Hipertensión.
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 1.617
- Centros
- 14
- Fin del objetivo primario
- ene 2010
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2007.
Qué mide
Reduction in mean SBP as measured by HBPM (From week 0 to week 24) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline. The secondary objectives are: * To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24 * To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24 * To compare the difference in mean SBP evaluated by HBPM at week 16 * To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24 * To determine the incidence and severity of adverse events
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00500604), actualizada en jul 2010.