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

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.

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Key information

Conditions

Hypertension Albuminuria Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

Basel, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Study to Describe Vascular and Renal Effects and Safety of Valsartan 80 and 160 mg in Arterial Hypertension Patients

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 15, 2005
Registry last updated: Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed