Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Hydrochlorothiazide; Indapamide; Losartan

Criteria

Inclusion Criteria:

• Adults male or female aged ≥ 18 years old;

• Patients with a diagnosis of Hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements,

• Patients with normal lab tests results in the last six months or that the investigator consider not clinically significant,

• Patient who accept the discontinuation of previous hypertension therapy.

Exclusion Criteria:

• Patients with blood pressure ≥ 180/100 mmHg;

• Patients with uncontrolled hypertension (≥ 140/90 mmHg) treated with thiazide diuretics;

• 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 ALT 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.

• Patients at the discretion of the investigator does not have indication for discontinuing the current medications;