Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Essential Arterial Hypertension

Treatments: Drug: Candesartan + Chlorthalidone (8 mg + 25 mg); Drug: Candesartan + Chlorthalidone (8mg+12,5mg); Drug: losartan+hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02521233

CACEMS0514OR-III

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 have never been treated and have indication for drug combination treatment.

Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements

Exclusion criteria

• Patients with any clinically significant disease that in the investigator is 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 in urine sample greater than 30 mg/g;
• Patients with history of hypersensitivity to any of the formula compounds;
• Pregnancy or risk of pregnancy and lactating 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 8 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Treatment:

Drug: Candesartan + Chlorthalidone (8mg+12,5mg)

Test 2: Candesartan + Chlorthalidone

Experimental group

Description:

The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning.

Treatment:

Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)

Comparator: losartan+hydrochlorothiazide (Hyzaar®)

Active Comparator group

Description:

he patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning.

Treatment:

Drug: losartan+hydrochlorothiazide