Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential 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 Olmesartan Medoxomil + Chlorthalidone (40mg + 12.5mg and 40mg + 25mg) Compared With BENICAR HCT® in Hypertension Control

Conditions
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Arterial Hypertension

Intervention / Treatment
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* Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg
* Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg
* Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg
* Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg


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 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;

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: Olmesartan+Chlorthalidone<br>The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 12,5 mg) a day, in the morning. | Drug: Olmesartan medoxomil 40mg + chlorthalidone 12,5mg<br>* 1 tablet a day<br>|
| Experimental: Test 2: Olmesartan+Chlorthalidone<br>The patients will take 1 tablet (Olmesartan medoxomil 40 mg + Chlorthalidone 25 mg) a day, in the morning. | Drug: Olmesartan medoxomil 40mg + chlorthalidone 25mg<br>* 1 tablet a day<br>|
| Active Comparator: Comparator 1: Benicar HCT®<br>The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 12,5 mg) a day, in the morning. | Drug: Olmesartan 40mg + Hydrochlorothiazide 12,5mg<br>* 1 tablet a day<br>* Other names: Benicar HCT;|
| Active Comparator: Comparator 2: Benicar HCT®<br>The patients will take 1 tablet (Olmesartan 40mg + Hydrochlorothiazide 25 mg) a day, in the morning. | Drug: Olmesartan 40mg + Hydrochlorothiazide 25mg<br>* 1 tablet a day<br>* Other names: Benicar HCT;|

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 the reduction of systolic blood pressure at the end of the study. |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | 9 weeks |