To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
127
Valsartan 3mg/kg oral solution
Valsartan 3 mg/kg oral solution
Novartis Investigative Site
Antwerp, Belgium
Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase
Time frame: Baseline, week 6
Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase
Time frame: Baseline, Week 6
Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6
Time frame: Week 6
CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6
UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR \[mg/mmol\] = urine albumin \[mg/L\] / urine creatinine \[mmol/L\] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6.
Time frame: Week 6 weeks
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Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
Curitibia, Paraná, Brazil
Novartis Investigative Site
Campinas, Brazil
Novartis Investigative Site
Caxias do Sul, Brazil
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Guatemala City, Guatemala
...and 17 more locations