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Clinical Trial Details

Trial ID: L0502
Source ID: NCT01365481
Associated Drug: Valsartan
Title: Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01365481/results
Conditions: Hypertension|Chronic Kidney Disease
Interventions: DRUG: Valsartan|DRUG: amlodipine|DRUG: Hydrochlorothiazide
Outcome Measures: Primary: 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., 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., Baseline, End Point (Week 78 or Last observation carried forward (LOCF) | Secondary: 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, 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, Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|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, Baseline, End Point (Week 78 or Last observation carried forward (LOCF)
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-08
Completion Date: 2015-09
Results First Posted: 2016-04-21
Last Update Posted: 2016-07-13
Locations: Novartis Investigative Site, Bucaramanga, Santander, 0001, Colombia|Novartis Investigative Site, Barranquilla, Colombia|Novartis Investigative Site, Cali, Colombia|Novartis Investigative Site, Helsinki, 00029, Finland|Novartis Investigative Site, Bochum, 44791, Germany|Novartis Investigative Site, Cottbus, 03048, Germany|Novartis Investigative Site, Freiburg, 79106, Germany|Novartis Investigative Site, Homburg, 66421, Germany|Novartis Investigative Site, Rostock, 18107, Germany|Novartis Investigative Site, Guatemala City, 01010, Guatemala|Novartis Investigative Site, Seoul, Korea, 03080, Korea, Republic of|Novartis Investigative Site, Manila, 1000, Philippines|Novartis Investigative Site, Quezon City, 1100, Philippines|Novartis Investigative Site, Quezon City, 1101, Philippines|Novartis Investigative Site, Warszawa, 04-154, Poland|Novartis Investigative Site, Cluj-Napoca, Jud Cluj, Romania|Novartis Investigative Site, Tg. Mures, jud Mures, 540104, Romania|Novartis Investigative Site, Timisoara, jud. Timis, 300011, Romania|Novartis Investigative Site, Bucuresti, 041451, Romania|Novartis Investigative Site, Bucuresti, 20395, Romania|Novartis Investigative Site, Iasi, 700309, Romania|Novartis Investigative Site, Kazan, 420012, Russian Federation|Novartis Investigative Site, Moscow, 119991, Russian Federation|Novartis Investigative Site, Moscow, 125315, Russian Federation|Novartis Investigative Site, Moscow, 127412, Russian Federation|Novartis Investigative Site, Voronezh, 394036, Russian Federation|Novartis Investigative Site, Singapore, 119074, Singapore|Novartis Investigative Site, Singapore, 229899, Singapore
URL: https://clinicaltrials.gov/show/NCT01365481