Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • Drug: Indapamide
    • Indapamide SR 1.5mg qd
  • Drug: Hydrochlorothiazide
    • Hydrochlorothiazide 25mg qd

Arms, Groups and Cohorts

  • Experimental: Indapamide
    • Indapamide SR 1.5mg qd
  • Active Comparator: Hydrochlorothiazide
    • Hydrochlorothiazide 25mg qd

Clinical Trial Outcome Measures

Primary Measures

  • renal function
    • Time Frame: 1 year
    • 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.

Secondary Measures

  • endothelial function
    • Time Frame: 1 year
    • 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.
  • blood pressure variability
    • Time Frame: 1 year
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West China Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaoping Chen, Xiaoping Chen, professor, West China Hospital of Sichuan University. – West China Hospital
  • Overall Official(s)
    • Xiao P Chen, master, Principal Investigator, West China Hospital

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