Clinical Trial Details
| Trial ID: | L1761 |
| Source ID: | NCT01617681 |
| Associated Drug: | Val489 |
| Title: | Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01617681/results |
| Conditions: | Pediatric Hypertension With or Without CKD |
| Interventions: | DRUG: VAL489|DRUG: VAL489 matching placebo |
| Outcome Measures: | Primary: 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, Baseline, week 6 | Secondary: 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, 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, 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., Week 6 weeks |
| Sponsor/Collaborators: | Sponsor: Novartis Pharmaceuticals |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE3 |
| Enrollment: | 127 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-11-08 |
| Completion Date: | 2017-01-24 |
| Results First Posted: | 2017-09-27 |
| Last Update Posted: | 2017-09-27 |
| Locations: | Novartis Investigative Site, Antwerpen, 2020, Belgium|Novartis Investigative Site, Liege, 4000, Belgium|Novartis Investigative Site, Curitibia, Parana, 80250-060, Brazil|Novartis Investigative Site, Campinas, 13087-567, Brazil|Novartis Investigative Site, Caxias do Sul, 95070-561, Brazil|Novartis Investigative Site, Porto Alegre, 90610-000, Brazil|Novartis Investigative Site, Montpellier, 34059, France|Novartis Investigative Site, Berlin, 13353, Germany|Novartis Investigative Site, Marburg, 35039, Germany|Novartis Investigative Site, Guatemala City, 01010, Guatemala|Novartis Investigative Site, Guatemala, 01001, Guatemala|Novartis Investigative Site, Guatemala, 1010, Guatemala|Novartis Investigative Site, Budapest, H 1096, Hungary|Novartis Investigative Site, Budapest, H-1083, Hungary|Novartis Investigative Site, Szeged, 6725, Hungary|Novartis Investigative Site, Bologna, BO, 40138, Italy|Novartis Investigative Site, San Donato Milanese, MI, 20097, Italy|Novartis Investigative Site, Palermo, 90134, Italy|Novartis Investigative Site, Vinius, 08406, Lithuania|Novartis Investigative Site, Bialystok, 15-274, Poland|Novartis Investigative Site, Gdansk, 80-952, Poland|Novartis Investigative Site, Krakow, 30-663, Poland|Novartis Investigative Site, Lodz, 93-338, Poland|Novartis Investigative Site, Lublin, 20-093, Poland|Novartis Investigative Site, Poznan, 61-825, Poland|Novartis Investigative Site, Szczecin, 71-252, Poland|Novartis Investigative Site, Warszawa, 04-154, Poland |
| URL: | https://clinicaltrials.gov/show/NCT01617681 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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