Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
NCT ID: NCT01617681
Last Updated: 2017-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
127 participants
INTERVENTIONAL
2012-11-08
2017-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Valsartan 0.25 mg/kg
Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
VAL489
Valsartan 3mg/kg oral solution
VAL489 matching placebo
Valsartan 3 mg/kg oral solution
Valsartan 4 mg/kg
Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
VAL489
Valsartan 3mg/kg oral solution
VAL489 matching placebo
Valsartan 3 mg/kg oral solution
Valsartan 1 mg/kg
Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.
VAL489
Valsartan 3mg/kg oral solution
Interventions
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VAL489
Valsartan 3mg/kg oral solution
VAL489 matching placebo
Valsartan 3 mg/kg oral solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1 Year
5 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Antwerp, , Belgium
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
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
San Donato Milanese, MI, Italy
Novartis Investigative Site
Palermo, , Italy
Novartis Investigative Site
Vinius, , Lithuania
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Lublin, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Szczecin, , Poland
Novartis Investigative Site
Warsaw, , Poland
Countries
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References
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Jankauskiene A, Drozdz D, Wasilewska A, de Paula-Bernardes R, Glazer R, Valentin M, Tan M, Chiang Y, Bapatla K. Efficacy and safety of valsartan in children aged 1-5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase. Curr Med Res Opin. 2021 Dec;37(12):2113-2122. doi: 10.1080/03007995.2021.1982681. Epub 2021 Oct 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-005991-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CVAL489K2306
Identifier Type: -
Identifier Source: org_study_id