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

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): 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

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: July 2004
Last updated: August 6, 2007