NCT00171028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 8, 2011

Status Verified

June 1, 2006

Enrollment Period

2.9 years

First QC Date

September 10, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

PEDIATRIC HYPERTENSIONPEDIATRICVALSARTAN

Outcome Measures

Primary Outcomes (1)

  • Change from baseline systolic blood pressure after 2 and 4 weeks

Secondary Outcomes (5)

  • 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

Interventions

valsartanDRUG

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • BLOOD PESSURE IS =\>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER \& HEIGHT
  • SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • 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.

    PMID: 18591457DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

December 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 8, 2011

Record last verified: 2006-06

Locations

US(1)