A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension

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 hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 – 5 years old whose parents 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 Hypertension Patients 1 – 5 Years Of Age

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

Primary outcome: Change from baseline systolic blood pressure after 2 and 4 weeks

Secondary outcome:

Change from baseline systolic blood pressure after 4 weeks

Change from baseline diastolic blood pressure after 2 weeks

Change in 2 week diastolic blood pressure after 2 more weeks

Change in baseline diastolic blood pressure after 4 weeks

Adverse events, serious adverse events, and laboratory values during 4 weeks

Minimum age: 1 Year. Maximum age: 5 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER & HEIGHT

- PARENTAL CONSENT MUST BE GRANTED

Exclusion Criteria:

- BLOOD PESSURE IS =>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER & HEIGHT

- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS

Other protocol-defined exclusion criteria will apply.

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

Starting date: December 2003
Last updated: June 1, 2006