Albuminuria
Conditions
Keywords
Albuminuria, Type 2 diabetes mellitus, Hypertension
Brief summary
Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Inclusion criteria
* Mild to moderate hypertension * Type 2 diabetes mellitus * Presence of protein in the urine (albuminuria)
Exclusion criteria
* Kidney disease not caused by diabetes or hypertension * Renal artery stenosis * Myocardial infarction or stroke within the last 6 months * Type 1 diabetes mellitus * Pregnant or lactating females * Cancer within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the urine albumin/creatinine ratio after 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks | — |
| Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks | — |
| Change from baseline in insulin resistance after 52 weeks | — |
| Change from baseline in urine albumin secretion after 52 weeks | — |
| Change from baseline in a marker of heart failure after 52 weeks | — |
Outcome results
None listed