A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: valsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171041

CVAL489A2302

Details and patient eligibility

About

Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.

Enrollment

265 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =>95th PERCENTILE FOR AGE/GENDER/HEIGHT
CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED

Exclusion criteria

BLOOD PESSURE IS =>5% HIGHER THAN 99th PERCENTILE FOR AGE
SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS

Other protocol-defined inclusion/exclusion criteria will also apply.