Overview

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;