Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Sanofi192 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

Hypertension

Interventions

IrbesartanDRUG

Administration throughout the study period

IrbesartanDRUG

Administration throughout the study period

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Outcomes

Primary Outcomes

The difference of urinary albumin excretion rate change

Time frame: at week 24

Secondary Outcomes

Percentage of patients reaching target BP of 130/80mmHg

Time frame: At week 24

Adverse events

Time frame: From the beginning to the end of the study

Data from ClinicalTrials.gov

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