Assessment the Effect of Combined Treatment of diuretic 1.5mg/angiotensin receptor antagonists 50mg and diuretic 1.5mg/angiotensin receptor antagonists 100mg, Compared With 1.5 mg diuretic Monotherapy in the Treatment of Hypertensio

Phase 3

• Conditions: Hypertension; C14.907.489

• Registration Number: RBR-2cnzk7
• Lead Sponsor: Hospital do Coração/Associação do Sanatorio Sírio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the superiority of the fixed-dose association of two diuretic antihypertensive agents 1.5mg / angiotensin receptors and diuretic 50mg 1.5mg / angiotensin receptor 100 mg, compared to 1.5 mg monotherapy to treat diuretic uncontrolled essential hypertension (> 140/90 mmHg).<br>The primary variable for assessing the effectiveness will be obtained through the response rate of systolic and diastolic blood pressure, measured by the difference between the systolic blood pressure and diastolic blood pressure at baseline and at the final visit.<br>The confidence interval with 95% confidence for ?1 - ?2 will be built by ANCOVA (analysis of covariance), where ?2 is the average response rate of comparator drug and ?1 is the mean of the drug test1 (or test2).<br>The association shall be considered superior to monotherapy in the treatment of essential hypertension, if the lower limits of 95% for systolic blood pressure and diastolic blood pressure are greater than 0.475 and 0.19, respectively.