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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00171353
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland