Overview

Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
West China Hospital
Treatments:
Hydrochlorothiazide
Indapamide
Criteria
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.