Hypertension
Conditions
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
Interventions
DRUGIrbesartan
Administration throughout the study period
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of urinary albumin excretion rate change | at week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients reaching target BP of 130/80mmHg | At week 24 |
| Adverse events | From the beginning to the end of the study |
Countries
China
Outcome results
None listed