Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Novartis332 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

332

Conditions

Albuminuria

Interventions

amlodipine/benazeprilDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in the urine albumin/creatinine ratio after 52 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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