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

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

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.

Official title: A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in sitting systolic blood pressure after 2 weeks

Secondary outcome:

Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks

Change from baseline systolic blood pressure after 4 weeks

Change from baseline diastolic blood pressure after 2 weeks

Change in diastolic blood pressure after 2 weeks to 4 weeks

Change from baseline diastolic blood pressure after 4 weeks

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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.

Investigative Centers, Germany

Novartis Pharmaceuticals, E.Hanover, New Jersey 07936, United States

Starting date: December 2002
Last updated: April 23, 2007