drugset / Trial / NCT00971165

Diuretics and Angiotensin-Receptor Blocker Agents in Patients With Stage I Hypertension

NCT00971165

RandomizedParallel-groupQuadruple-blindTreatment

Summary

High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults. The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo. Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride. A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.

Timeline

Start
2010-07
Primary completion
2014-09
Completion
2014-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amiloride Small molecule 2.5 mg Oral
Comparator Amiloride Small molecule 5 mg Oral
Comparator Chlorthalidone Other / unclassified 12.5 mg Oral
Comparator Chlorthalidone Other / unclassified 25 mg Oral
Subject Losartan Other / unclassified 50 mg Oral
Subject Losartan Other / unclassified 100 mg Oral

Indications