Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Irbesartan
  • Administration throughout the study period
• Drug: Irbesartan
  • Administration throughout the study period

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Irbesartan 150mg
• Experimental: 2
  • Irbesartan 300mg

Primary Measures

• The difference of urinary albumin excretion rate change
  • Time Frame: at week 24
    Safety Issue?: No

Secondary Measures

• Percentage of patients reaching target BP of 130/80mmHg
  • Time Frame: At week 24
    Safety Issue?: No
• Adverse events
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Bruno Jolain Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00334581

Study ID Number: IRBES_L_00907

ClinicalTrials.gov Identifier: NCT00334581

Health Authority: China: State Food and Drug Administration