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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00171353
Enrollment
109
Registered
2005-09-15
Start date
2004-07-31
Completion date
2005-09-30
Last updated
2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

arterial hypertension, albuminuria, valsartan

Brief summary

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.

Interventions

DRUGvalsartan

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026