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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Hypertension

Treatments

Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171353
CVAL489ARU01

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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