Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.

Official Title
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A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Old Patients With Mild to Moderate Renal Insufficiency and Hypertension

Conditions
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Hypertension, Renal Insufficiency

Intervention / Treatment
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* Drug: Indapamide
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation. Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs. Aged between 65 and 85 years. Willingness to provide written, informed consent. Ability to adhere to study protocol. Exclusion Criteria: Secondary hypertension. Diabetes mellitus. Atrial flutter/atrial fibrillation. Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF < 40%. Recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms. Recent (< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft). Severe valvular heart disease. History of hypersensitivity to indapamide, thiazides or to any of the components of the products. Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs. Participation to another investigational study in the last 3 months.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Indapamide<br>Indapamide SR 1.5mg qd | Drug: Indapamide<br>* Indapamide SR 1.5mg qd<br>|
| Active Comparator: Hydrochlorothiazide<br>Hydrochlorothiazide 25mg qd | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide 25mg qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function | Effects of indapamide SR 1.5 mg on renal function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | Effects of indapamide SR 1.5 mg on endothelial function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension. | 1 year | 
| blood pressure variability | Effects of indapamide SR 1.5 mg on blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, renal insufficiency, indapamide, hydrochlorothiazide