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

This study has been terminated.

First Received on September 10, 2005. Last Updated on December 16, 2008 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171119

Purpose

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.

Condition	Intervention	Phase
Hypertension Diabetic Nephropathy	Drug: valsartan	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Diabetic Kidney Problems High Blood Pressure Urine and Urination

Drug Information available for: Benazepril hydrochloride Benazepril Valsartan Lotrel

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in urine albumin excretion rate after 24 weeks

Secondary Outcome 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

Enrollment:	81
Study Start Date:	January 2004
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171119

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00171119 History of Changes
Other Study ID Numbers:	CVAL489ATR05
Study First Received:	September 10, 2005
Last Updated:	December 16, 2008
Health Authority:	Turkey: Ministry of Health

Keywords provided by Novartis:

HYPERTENSION
DIABETES MELLITUS TYPE II
VALSARTAN
BENAZAPRIL

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Hypertension
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases

Benazepril
Valsartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012