A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

Novartis

Status and phase

Terminated

Phase 4

Conditions

Diabetic Nephropathy

Hypertension

Treatments

Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171119

CVAL489ATR05

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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 exclusion criteria may apply.