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

Novartis

Status and phase: Completed; Phase 4

Conditions: Albuminuria

Treatments: Drug: amlodipine/benazepril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00136773

CCIB002FUS12

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind