A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure

This study has been completed.

First Received on September 12, 2005. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00171353

Purpose

One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.

Condition	Intervention	Phase
Hypertension	Drug: valsartan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study to Describe Vascular and Renal Effects and Safety of Valsartan 80 and 160 mg in Arterial Hypertension Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Urine and Urination

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in urine albumin excretion after 24 weeks
Change from baseline in an ultrasound measurement of blood flow after 24 weeks

Secondary Outcome Measures:

Effect of blood pressure changes on urine albumin excretion rate and blood vessel function

Enrollment:	109
Study Start Date:	July 2004
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Arterial hypertension without previous regular treatment
Urinary albumin excretion rate above 30 mg / 24h
30-65 years old

Exclusion Criteria:

Reno-vascular arterial hypertension
Therapy resistant edema
Chronic heart failure, angina pectoris
Diabetes mellitus

Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171353

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171353 History of Changes
Other Study ID Numbers:	CVAL489ARU01
Study First Received:	September 12, 2005
Last Updated:	November 7, 2011
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:

arterial hypertension
albuminuria
valsartan

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012