Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Essential Arterial Hypertension

Treatments: Drug: Losartan+hydrochlorothiazide; Drug: Candesartan + Chlorthalidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02521246

CACEMS0315

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.

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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0 participants in 3 patient groups

Test 1: Candesartan + Chlorthalidone

Experimental group

Description:

The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Treatment:

Drug: Candesartan + Chlorthalidone

Drug: Candesartan + Chlorthalidone

Test 2: Candesartan + Chlorthalidone

Experimental group

Description:

The patients will take 1 tablet (Candesartan Cilexetil 16 mg + Chlorthalidone 25 mg) a day, in the morning.

Treatment:

Drug: Candesartan + Chlorthalidone

Drug: Candesartan + Chlorthalidone

Comparator: Losartan+hydrochlorothiazide (Hyzaar®)

Active Comparator group

Description:

The patients will take 1 tablet (Losartan 100 mg + Hydrochlorothiazide 25 mg) a day, in the morning.

Treatment:

Drug: Losartan+hydrochlorothiazide