Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

NCT ID: NCT01172431

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Hypertension Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indapamide

Indapamide SR 1.5mg qd

Group Type EXPERIMENTAL

Indapamide

Intervention Type DRUG

Indapamide SR 1.5mg qd

Hydrochlorothiazide

Hydrochlorothiazide 25mg qd

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 25mg qd

Interventions

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Indapamide

Indapamide SR 1.5mg qd

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 25mg qd

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaoping Chen

Xiaoping Chen, professor, West China Hospital of Sichuan University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao P Chen, master

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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Department of Cardiology, West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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WestChinaH

Identifier Type: -

Identifier Source: org_study_id

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