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NCT00171353 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171353
Other study ID # CVAL489ARU01
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated November 7, 2011
Start date July 2004
Est. completion date September 2005

Study information
Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Russia: Pharmacological Committee, Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers
Gender Both
Age group 30 Years to 65 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in urine albumin excretion after 24 weeks
Primary Change from baseline in an ultrasound measurement of blood flow after 24 weeks
Secondary Effect of blood pressure changes on urine albumin excretion rate and blood vessel function
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