A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
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 Hypertensive Patients
1 other identifier
interventional
265
2 countries
2
Brief Summary
Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Dec 2002
Longer than P75 for phase_3 hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedNovember 18, 2016
November 1, 2016
3.2 years
September 10, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in sitting systolic blood pressure after 2 weeks
Secondary Outcomes (5)
Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic blood pressure after 2 weeks
Change in diastolic blood pressure after 2 weeks to 4 weeks
Change from baseline diastolic blood pressure after 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =\>95th PERCENTILE FOR AGE/GENDER/HEIGHT
- CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED
You may not qualify if:
- BLOOD PESSURE IS =\>5% HIGHER THAN 99th PERCENTILE FOR AGE
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Novartis Pharmaceuticals
E.Hanover, New Jersey, 07936, United States
Unknown Facility
Investigative Centers, Germany
Related Publications (1)
Wells T, Blumer J, Meyers KE, Neto JP, Meneses R, Litwin M, Vande Walle J, Solar-Yohay S, Shi V, Han G; Valsartan Pediatric Hypertension Study Group. Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension. J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18.
PMID: 21545397RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
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, 2002
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11