Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria
- Registration Number
- NCT00334581
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Irbesartan Irbesartan 150mg 2 Irbesartan Irbesartan 300mg
- Primary Outcome Measures
Name Time Method The difference of urinary albumin excretion rate change at week 24
- Secondary Outcome Measures
Name Time Method Percentage of patients reaching target BP of 130/80mmHg At week 24 Adverse events From the beginning to the end of the study
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇳Shanghai, China