Status:
COMPLETED
A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
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 tre...
Eligibility Criteria
Inclusion
- CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =\>95th PERCENTILE FOR AGE/GENDER/HEIGHT
- CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED
Exclusion
- BLOOD PESSURE IS =\>5% HIGHER THAN 99th PERCENTILE FOR AGE
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
- Other protocol-defined inclusion/exclusion criteria will also apply.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00171041
Start Date
December 1 2002
End Date
March 1 2006
Last Update
November 18 2016
Active Locations (2)
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1
Novartis Pharmaceuticals
E.Hanover, New Jersey, United States, 07936
2
Investigative Centers, Germany