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Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Information source: West China Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Renal Insufficiency

Intervention: Indapamide (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: West China Hospital

Official(s) and/or principal investigator(s):
Xiao P Chen, master, Principal Investigator, Affiliation: West China Hospital


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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: renal function

Secondary outcome:

endothelial function

blood pressure variability


Minimum age: 65 Years. Maximum age: 85 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Department of Cardiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
Additional Information

Starting date: September 2010
Last updated: June 23, 2014

Page last updated: August 23, 2015

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