Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.

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

Details

• Lead Sponsor: EMS
• Treatments: Chlorthalidone; Hydrochlorothiazide; Losartan; Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• Signed Consent of the patient;

• Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who are being treated with monotherapy.

Exclusion Criteria:

• Patients with any clinically significant disease that in the investigator opinion can not participate in the study;

• Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;

• Morbid obesity or immunocompromised patients;

• Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;

• Participants who do not have the two upper limbs;

• Participants with important electrocardiographic changes;

• Creatinine clearance - less than 60 mL / min;

• History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;

• Microalbuminuria urine sample greater than 30 mg/g;

• Patients with history of hypersensitivity to any of the formula compounds;

• Pregnancy or risk of pregnancy and lactation patients;

• Participation in clinical trial in the year prior to this study;