Diabetic Nephropathy, Hypertension
Conditions
Keywords
HYPERTENSION, DIABETES MELLITUS TYPE II, VALSARTAN, BENAZAPRIL
Brief summary
The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.
Interventions
DRUGvalsartan
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Inclusion criteria
* male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria * patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry * patients who give written, signed, informed consent. * patients with/without mild /moderate hypertension. * patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment. * patients without any accompanying systemic disease
Exclusion criteria
* pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception * patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in urine albumin excretion rate after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients returning to normal urine albumin excretion rate after 24 weeks | — |
| Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry | — |
Countries
Switzerland
Outcome results
None listed