Hypertension
Conditions
Interventions
Experimental Group 1: 85 patients should take diuretic 1.5mg / angiotensin receptor 50 mg tablet + 1 placebo diuretic (for blinding) once daily in the morning for 12 weeks.
Experimental Group 2: 85 pa
Drug
Sponsors
Dr. José Vilela Martin
Dr. Luiz Carlos Bodanese
Hospital do Coração/Associação do Sanatorio Sírio
Dr. Celso Amodeo
Dr. Estêvão Lanna Figueiredo
Dr. Renato Delascio Lopes
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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. 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). 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage (%) of patients with blood pressure levels <140/90 mmHg at 12 weeks; Percentage (%) of patients excluded from the study for treatment failure; Time to adequate control of systolic and diastolic blood pressure (BP <140/90 mmHg); Evaluation of the incidence of adverse events; The safety assessment of study medication will be provided through the registry of any adverse events, episodes of hypotension serious adverse events and unexpected reactions to the drug. Still, the following blood tests for safety monitoring will be performed: fasting blood glucose, complete blood count and platelet count, assessment of liver function (ALT, AST), sodium, potassium and assessment of renal function (creatinine). The 95% will be constructed and analyzed in a similar way to the primary variable for those continuous variables. The confidence interval with 95% confidence p1 - p2 is constructed by ANCOVA (analysis of covariance) for proportions, where p2 is the rate of response comparison of the drug and the drug is p1 test1 and test2. For categorical variables, categorical change test, as McNemar test and Stuart-Maxwell test is applied for comparison between visits (compared within each product) and chi-square test to compare the drugs. | — |
Countries
Brazil
Contacts
Public ContactClaudia Freitas
EMS
Outcome results
None listed