Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Irbesartan (Drug); Irbesartan (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Bruno Jolain, Study Director, Affiliation: Sanofi
Summary
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
Clinical Details
Official title: A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The difference of urinary albumin excretion rate change
Secondary outcome: Percentage of patients reaching target BP of 130/80mmHgAdverse events
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Sanofi-Aventis Administrative Office, Shanghai, China
Additional Information
Starting date: May 2006
Last updated: September 14, 2009
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