Skip to main content
OpenTrials
Completed

NCT Number: NCT00334581

Irbesartan in Chinese Hypertensive Diabetics With 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan

Drug

Administration throughout the study period

Primary outcomes

  1. The difference of urinary albumin excretion rate change

    Time frame: at week 24

Secondary outcomes

  1. Percentage of patients reaching target BP of 130/80mmHg

    Time frame: At week 24

  2. Adverse events

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 8, 2006
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.