Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.

Detailed Description
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To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form. Some eligibility criteria: perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram

Official Title
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A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension

Conditions
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Arterial Hypertension

Intervention / Treatment
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* Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg
* Drug: Higroton® Laboratório Novartis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systolic blood pressure between 140 mmHg - 159 mmHg Diastolic blood pressure between 90 mmHg - 99 mmHg Subject aged ≥ 60 years old Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project. Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration. Exclusion Criteria: Any serious or severe clinically significant medical condition. Psychiatric or neurological diseases A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient. Participation in any other investigational study within 12 months prior to Visit 1. Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study Routine prior use of diuretics Oral anticoagulant use Fast glycemia > 150 mg/dL Medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up. Expected onset of additional antihypertensive drug after the study onset Acute myocardial infarction within last 6 months Prior decompensated coronary artery disease Known thyroid, renal or liver dysfunction, at investigator's discretion Obesity - body mass index (BMI) > 33 kg/m2

Ages Eligible for Study
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Minimum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higroton®<br>Chlorthalidone 25mg - one oral tablet a day in the morning | Drug: Higroton® Laboratório Novartis<br>* Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks<br>|
| Experimental: Diupress®<br>Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning | Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg<br>* Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks<br>* Other names: Diupress® (Eurofarma Laboratórios Ltda.);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potassium level | Potassium level <4.0 mEq/L after starting the medication. | After starting the medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Will be considered as secondary outcomes BP <140 X 90 mmHg after 12 weeks of treatment. | After 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlortalidone, amiloride, arterial hypertension