Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01172431

Enrollment

240

Registered

2010-07-29

Start date

2010-09-30

Completion date

2013-12-31

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Renal Insufficiency

Keywords

hypertension, renal insufficiency, indapamide, hydrochlorothiazide

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.

Interventions

DRUGIndapamide

Indapamide SR 1.5mg qd

DRUGHydrochlorothiazide

Hydrochlorothiazide 25mg qd

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026