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 Small molecule 80 mg
Comparator Valsartan Small molecule 160 mg
Background Hydrochlorothiazide Unknown 12.5 mg Oral

Indications