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Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

NCT00435162 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2011-05-09

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).

Conditions

Interventions

DRUG

Valsartan 0.25 mg/kg

once daily

DRUG

Valsartan 1.0 mg/kg

once daily

DRUG

Valsartan 4.0 mg/kg

once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Hungary
  • India
  • Italy
  • Poland
  • South Africa
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00435162 on ClinicalTrials.gov