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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: valsartan

Primary Measures

• Change from baseline in urine albumin excretion rate after 24 weeks

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171119

Study ID Number: CVAL489ATR05

ClinicalTrials.gov Identifier: NCT00171119

Health Authority: Turkey: Ministry of Health