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

Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in Hypertension Control

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

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;