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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Extemporaneous suspension of valsartan, orally.
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Time frame: Baseline to Week 26
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Time frame: Baseline to Week 26
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Time frame: Week 8 to Week 26 of Extension Phase
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Novartis Investigative Site
Hackensack, New Jersey, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Norfolk, Virginia, United States
Novartis Investigative Site
Antwerp, Belgium
Novartis Investigative Site
Edegem, Belgium
Novartis Investigative Site
Ghent, Belgium
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Laken, Belgium
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Liège, Belgium
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Goiânia, Goiás, Brazil
Novartis Investigative Site
Curitiba, Paraná, Brazil
...and 26 more locations