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

EMS

Status and phase: Not yet enrolling; Phase 3

Conditions: Arterial Hypertension

Treatments: Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg; Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg; Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg; Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02483936

OLCEMS0215

Details and patient eligibility

About

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

Enrollment: 348 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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348 participants in 4 patient groups

Test 1: Olmesartan+Chlorthalidone

Experimental group

Description:

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Treatment:

Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg

Test 2: Olmesartan+Chlorthalidone

Experimental group

Description:

The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning.

Treatment:

Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg

Comparator 1: Benicar HCT®

Active Comparator group

Description:

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.

Treatment:

Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg

Comparator 2: Benicar HCT®

Active Comparator group

Description:

The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning.

Treatment:

Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg