The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Sites in USA
East Hanover, New Jersey, United States
Sites in Belgium
Sites in Belgium, Belgium
Sites in France
Sites in France, France
Sites in Germany
Sites in Germany, Germany
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.
Time frame: Baseline and Week 12
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.
Time frame: Baseline and Week 12
Decrease in MSSBP to < 95th Percentile for Age, Gender and Height
The percentage of children whose MSSBP decreased to \<95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.
Time frame: at week 12
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients
The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.
Time frame: Baseline and Week 8
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Sites in Hungary
Hungary, Hungary
Sites in India
Sites in India, India
Sites in Italy
Sites in Italy, Italy
Sites in Poland
Poland, Poland
Sites in Slovakia
Slovakia, Slovakia
Sites in Sweden
Sites in Sweden, Sweden
...and 1 more locations