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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171028

Enrollment

Registered

2005-09-15

Start date

2003-12-31

Completion date

2006-11-30

Last updated

2011-11-08

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 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.

Interventions

DRUGvalsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline systolic blood pressure after 2 and 4 weeks	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

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