drugset / Trial / NCT00500604

Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

NCT00500604 ↗

Phase 4 Completed 1617 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The 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

Timeline

Start
2007-07
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Irbesartan Small molecule 150 mg —
Subject Irbesartan Small molecule 300 mg —
Comparator Valsartan Unknown 80 mg —
Comparator Valsartan Unknown 160 mg —
Background Hydrochlorothiazide Unknown 12.5 mg Oral

Indications