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CompletedNCT00171028Updated Nov 8, 2011

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

A Phase 3 interventional study of valsartan in Hypertension, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2011-11-08.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • PEDIATRIC HYPERTENSION
  • PEDIATRIC
  • VALSARTAN
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 90 is close to the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER \& HEIGHT
  • PARENTAL CONSENT MUST BE GRANTED

Exclusion criteria

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
90 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline systolic blood pressure after 2 and 4 weeks

Secondary outcomes

  1. Change from baseline systolic blood pressure after 4 weeks

  2. Change from baseline diastolic blood pressure after 2 weeks

  3. Change in 2 week diastolic blood pressure after 2 more weeks

  4. Change in baseline diastolic blood pressure after 4 weeks

  5. Adverse events, serious adverse events, and laboratory values during 4 weeks

07

Study locations

1 site
  • Novartis Pharmaceuticals
    East Hanover, New Jersey 07936, United States
08

References and documents

Publications

  • Flynn JT, Meyers KE, Neto JP, de Paula Meneses R, Zurowska A, Bagga A, Mattheyse L, Shi V, Gupte J, Solar-Yohay S, Han G; Pediatric Valsartan Study Group. Efficacy and safety of the Angiotensin receptor blocker valsartan in children with hypertension aged 1 to 5 years. Hypertension. 2008 Aug;52(2):222-8. doi: 10.1161/HYPERTENSIONAHA.108.111054. Epub 2008 Jun 30. PubMed 18591457 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00171028
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Dec 2003
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Nov 8, 2011

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Valsartan

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