Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Phase 4

Completed

• Conditions: Hypertension; Renal Insufficiency
• Interventions: Drug: Hydrochlorothiazide; Drug: Indapamide

• Registration Number: NCT01172431
• Lead Sponsor: West China Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Study Start: 2010-09
• Primary Completion: 2012-03
• Study Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrochlorothiazide	Hydrochlorothiazide	Hydrochlorothiazide 25mg qd
Indapamide	Indapamide	Indapamide SR 1.5mg qd

Primary Outcome Measures

Name	Time	Method
renal function	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 Outcome Measures

Name	Time	Method
endothelial function	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	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

Trial Locations

Locations (1)

Department of Cardiology, West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China