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

Phase 4

Terminated

• Conditions: Hypertension; Diabetic Nephropathy

• Registration Number: NCT00171119
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-03
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-16
• Last Update Posted: 2008-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in urine albumin excretion rate after 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland