Randomized, phase III, multicenter, double-blind, double-dummy trial to assess the effect of combined treatment of Indapamide 1.5mg / Losartan 50 mg and Indapamide 1.5mg / Losartan 100mg, compared to monotherapy Indapamide 1.5 mg in the treatment of essential hypertension

Hospital do Coração/Associação do Sanatorio Sírio0 个研究点开始时间: 2015年4月7日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Patients of both sexes, aged <18 years; Patients with systemic hypertension (defined by medical researcher) alone (not by thiazide diuretic) and have at least two blood pressure measurements <140/90, in sitting position, with 5 minutes interval; Patients with laboratory test results, in a period of up to 6 months before, within normal values ??(chemistry, hematology and urinalysis) or that the researcher considers them not clinically significant;
•Patient who is willing to continue treatment for hypertension with medications the study. In this case, the patient will be randomized to drug or the combined use of thiazide diuretic, which would be internationally recommended drug for treating essential hypertension. If the patient is using other drug class, to include it in the study and perform the exchange of medication thiazide diuretic, it will be getting the best treatment available and recommended by national and international guidelines for its pathology.

•Patients with blood pressure , 180/100 mmHg;Presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine> 1.5 mg / dL);Patients with hypo or hyperkalemia (serum potassium outside normal range); Patients with alanine aminotransferase greater than 2.5 the upper limit of normal or active liver disease; Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period; Patients on drug or alcohol abuse in the last two years; Patients with secondary hypertension (renovascular disease, pheochromocytoma, Cushing's syndrome); Patients with allergic reactions or hypersensitivity to ACE inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation; Refusal or inability to provide the Informed Consent Term.; Refusal to discontinue the anti-hypertensive medication.

发起方

Hospital do Coração/Associação do Sanatorio Sírio