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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00171119
• Other study ID #: CVAL489ATR05
• Status: Terminated
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: December 16, 2008
• Start date: January 2004

Study information

• Verified date: December 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. primary completion date: March 2005
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Hypertension

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urine albumin excretion rate after 24 weeks
Secondary	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
Secondary	Percent of patients returning to normal urine albumin excretion rate after 24 weeks