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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00171041
Enrollment
265
Registered
2005-09-15
Start date
2002-12-31
Completion date
2006-03-31
Last updated
2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

PEDIATRIC HYPERTENSION, PEDIATRIC, VALSARTAN

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.

Interventions

DRUGvalsartan

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years

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/

Design outcomes

Primary

MeasureTime frame
Change from baseline in sitting systolic blood pressure after 2 weeks—

Secondary

MeasureTime frame
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—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026