drugset / Trial / NCT00751751

Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

NCT00751751

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.

Timeline

Start
2003-06
Primary completion
2005-04
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Losartan Other / unclassified 50 mg Oral
Comparator Losartan Other / unclassified 100 mg Oral
Subject Olmesartan medoxomil Unknown 20 mg Oral
Subject Olmesartan medoxomil Unknown 40 mg Oral
Background Hydrochlorothiazide Unknown 12.5 mg Oral
Background Hydrochlorothiazide Unknown 25 mg Oral