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

Study Overview
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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.

Official Title
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Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control

Conditions
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Essential Arterial Hypertension

Intervention / Treatment
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* Drug: Candesartan + Chlorthalidone (8mg+12,5mg)
* Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)
* Drug: losartan+hydrochlorothiazide


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test 1: Candesartan + Chlorthalidone<br>The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 12,5 mg) a day, in the morning. | Drug: Candesartan + Chlorthalidone (8mg+12,5mg)<br> <br> * Other names: Candesartan + Chlorthalidone;|
| Experimental: Test 2: Candesartan + Chlorthalidone<br>The patients will take 1 tablet (Candesartan cilexetil 8 mg + Chlorthalidone 25 mg) a day, in the morning. | Drug: Candesartan + Chlorthalidone (8 mg + 25 mg)<br> <br> * Other names: Candesartan + Chlorthalidone;|
| Active Comparator: Comparator: losartan+hydrochlorothiazide (Hyzaar®)<br>he patients will take 1 tablet (Losartan 50 mg + Hydrochlorothiazide 12,5 mg) a day, in the morning. | Drug: losartan+hydrochlorothiazide<br> <br> * Other names: Hyzaar ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the occurrences of adverse events. |  | 9 weeks |