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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: June 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
Outcome Measures for this Clinical Trial
Primary Measures
- The difference of urinary albumin excretion rate change
- Time Frame: at week 24
Safety Issue?: No
- Time Frame: at week 24
Secondary Measures
- Percentage of patients reaching target BP of 130/80mmHg
- Time Frame: At week 24
Safety Issue?: No
- Time Frame: At week 24
- Adverse events
- Time Frame: From the beginning to the end of the study
Safety Issue?: Yes
- Time Frame: From the beginning to the end of the study
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Bruno Jolain Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00334581
