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IRBESARTAN · I-COMBO

Irbesartan and Amlodipine Combination in Controlling Blood Pressure

Ensayo de Sanofi en Hipertension.

Fase: Fase 2
Estado: Completado
Participantes: 270
Centros: 4
Fin del objetivo primario: ene 2010

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en jul 2009.

Qué mide

Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo (At week 0, week 2, week 4 and week 8) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo. The secondary objectives are: * to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo. * to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.

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Ficha completa en ClinicalTrials.gov (NCT00950066), actualizada en ene 2011.