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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Benazepril; Valsartan

Criteria

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.