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

Novartis90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

valsartanDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline systolic blood pressure after 2 and 4 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.