Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

September 14, 2009 updated by: Sanofi

A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Shanghai, China
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Irbesartan 150mg
Administration throughout the study period
Experimental: 2
Irbesartan 300mg
Administration throughout the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference of urinary albumin excretion rate change
Time Frame: at week 24
at week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients reaching target BP of 130/80mmHg
Time Frame: At week 24
At week 24
Adverse events
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: Bruno Jolain, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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