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

Novartis109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Hypertension

Interventions

valsartanDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

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

Data from ClinicalTrials.gov

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