Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Sichuan University

Status and phase

Completed

Phase 4

Conditions

Hypertension

Renal Insufficiency

Treatments

Drug: Hydrochlorothiazide

Drug: Indapamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01172431

WestChinaH

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

65 to 85 years old

Volunteers

No 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.