The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily
added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
Novartis Investigative Site
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height
Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height
Time frame: End Point (Week 78 or Last observation carried forward (LOCF)
Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point
Percentage of Patients with CKD who had Urine albumin creatinine reduction \>/= 50% from baseline
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
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Bucaramanga, Santander Department, Colombia
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Helsinki, Finland, Finland
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Cottbus, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Homburg, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
...and 18 more locations
Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point
Percentage of Patients with CKD who had eGFR decrease \> 25 % from Baseline
Time frame: Baseline, End Point (Week 78 or Last observation carried forward (LOCF)