Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

Phase 3 Completed 127 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2012-11-08
Primary completion: 2017-01-24
Completion: 2017-01-24

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valsartan	Small molecule	0.25 mg/kg	Oral
Subject	Valsartan	Small molecule	1 mg/kg	Oral
Subject	Valsartan	Small molecule	2 mg/kg	Oral
Subject	Valsartan	Small molecule	3 mg/kg	Oral
Subject	Valsartan	Small molecule	4 mg/kg	Oral

Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

Summary

Timeline

Publications

Drugs

Indications