The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
once daily
once daily
once daily
Sites in USA
USA, New Jersey, United States
Sites in Belgium
Belgium, Belgium
Sites in Brazil
Brazil, Brazil
Sites in France
Paris, France
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
Time frame: baseline and week 6
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
Time frame: baseline and week 6
Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Time frame: week 6 and week 8
Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
Time frame: week 6 and week 8
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Sites in Hungary
Hungary, Hungary
Sites in India
India, India
sites in Italy
Italy, Italy
Sites in Poland
Poland, Poland
Sites in South Africa
South Africa, South Africa
Sites in Sweden
Sweden, Sweden
...and 1 more locations