Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.

This study has been completed.

First Received: September 12, 2005 Last Updated: February 28, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171561

Purpose

The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.

Condition	Intervention	Phase
Hypertension	Drug: valsartan/hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure Urine and Urination

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Blood measures of hypertension after 24 weeks

Secondary Outcome Measures:

Blood measures of hypertension in arterial system after 24 weeks
Change in protein excretion rate after 24 weeks
Change in serum markers of endothelial function and oxidative stress after 24 weeks

Estimated Enrollment:	124
Study Start Date:	March 2003
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

type 2 diabetes
elevated blood pressure and pulse pressure
albuminuria

Exclusion Criteria:

Severe hypertension
History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
Liver, kidney (not caused by diabetes), or pancreas disease
Type 1 diabetes or uncontrolled type 2 diabetes
Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171561

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAH631B2404
Study First Received:	September 12, 2005
Last Updated:	February 28, 2007
ClinicalTrials.gov Identifier:	NCT00171561 History of Changes
Health Authority:	United Kingdom: National Health Service

Keywords provided by Novartis:

hypertension
diabetes
albuminuria

valsartan
hydrochlorothiazide
amlodipine

Additional relevant MeSH terms:

Vasodilator Agents
Albuminuria
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010