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A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

NCT00457626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-09-05

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.

Conditions

Interventions

DRUG

Valsartan

Extemporaneous suspension of valsartan, orally.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-04-09
Primary Completion
2009-05-25
Completion
2009-05-25
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Hungary
  • India
  • Italy
  • Poland
  • South Africa
  • 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 NCT00457626 on ClinicalTrials.gov