Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus

This study has been completed.

First Received: October 14, 2005 Last Updated: June 1, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241085

Purpose

This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.

Condition	Intervention	Phase
Proteinuria Hypertension Type 2 Diabetes	Drug: valsartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Multi-Center, Double Blind, Randomized, Parallel Group Study to Evaluate the Effects of Valsartan on Proteinuria in Hypertensive Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in urinary protein excretion after 30 weeks

Secondary Outcome Measures:

Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 weeks

Estimated Enrollment:

369

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,

Exclusion Criteria:

Pregnant or breast feeding, Type 1 diabetes

Other protocol criteria apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241085

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Weir MR, Hollenberg NK, Zappe DH, Meng X, Parving HH, Viberti G, Remuzzi G. Antihypertensive effects of double the maximum dose of valsartan in African-American patients with type 2 diabetes mellitus and albuminuria. J Hypertens. 2010 Jan;28(1):186-93.

Study ID Numbers:	CVAL489A2417
Study First Received:	October 14, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00241085 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

proteinuria
hypertension
valsartan
type 2 diabetes

Additional relevant MeSH terms:

Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Proteinuria
Urologic Diseases
Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 09, 2010