Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Phase 4
Completed
- Conditions
- Albuminuria
- Registration Number
- NCT00136773
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in the urine albumin/creatinine ratio after 52 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in urine albumin secretion after 52 weeks Change from baseline in a marker of heart failure after 52 weeks 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