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

Novartis1 site in 1 country265 target enrollmentDecember 2002

ConditionsHypertension

Drugsvalsartan

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 265
Locations: 1
Primary Endpoint: Change from baseline in sitting systolic blood pressure after 2 weeks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

March 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Change from baseline in sitting systolic blood pressure after 2 weeks

Secondary Outcomes

Change in diastolic blood pressure after 2 weeks to 4 weeks
Change from baseline diastolic blood pressure after 2 weeks
Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic blood pressure after 4 weeks
Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks