Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

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

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-06-30

Brief Summary

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Primary objective:

* To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.

Secondary objectives:

* To determine how well irbesartan 300mg is tolerated versus 150mg
* To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg

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Detailed Description

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Conditions

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Hypertension

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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1

Irbesartan 150mg

Group Type EXPERIMENTAL

Irbesartan

Intervention Type DRUG

Administration throughout the study period

2

Irbesartan 300mg

Group Type EXPERIMENTAL

Irbesartan

Intervention Type DRUG

Administration throughout the study period

Interventions

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Irbesartan

Administration throughout the study period

Intervention Type DRUG

Irbesartan

Administration throughout the study period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
* Blood pressure of \< 180/110mmHg at baseline
* Normal serum creatinine

Exclusion Criteria

* Type 1 diabetes
* Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
* Pregnant or lactating women
* Severe hypertension
* Overt nephropathy
* Allergy to study drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No