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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Essential Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test 1: Candesartan + Chlorthalidone

The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Test 2: Candesartan + Chlorthalidone

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

Group Type EXPERIMENTAL

Candesartan + Chlorthalidone (8 mg + 25 mg)

Intervention Type DRUG

Comparator: losartan+hydrochlorothiazide (Hyzaar®)

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

Group Type ACTIVE_COMPARATOR

losartan+hydrochlorothiazide

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Candesartan + Chlorthalidone (8 mg + 25 mg)

Intervention Type DRUG

losartan+hydrochlorothiazide

Intervention Type DRUG

Other Intervention Names

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Candesartan + Chlorthalidone Candesartan + Chlorthalidone Hyzaar ®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No