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

Novartis265 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

265

Conditions

Hypertension

Interventions

valsartanDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (2)

Novartis Pharmaceuticals

E.Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in sitting systolic blood pressure after 2 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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