drugset / Trial / NCT00708344

ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

NCT00708344

Phase 4 Completed 832 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.

Timeline

Start
2008-06
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrochlorothiazide Unknown 12.5 mg
Comparator Hydrochlorothiazide Unknown 25 mg
Comparator Irbesartan Small molecule 150 mg
Comparator Irbesartan Small molecule 300 mg

Indications