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

Condition(s) targeted: Hypertension; Diabetic Nephropathy

Intervention: valsartan (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

Official title: A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in urine albumin excretion rate after 24 weeks

Secondary outcome:

Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry

Percent of patients returning to normal urine albumin excretion rate after 24 weeks

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: January 2005
Last updated: August 6, 2007