A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

Phase 3 Completed 66 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.

Timeline

Start: 2007-04-09
Primary completion: 2009-05-25
Completion: 2009-05-25

Outcome

Missed primary endpoint

paper statistical significance was not achieved during the dose ranging (primary endpoint) PMID 23511339 ↗

Publications

Results Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Valsartan	Unknown	1 mg/kg	Oral
Subject	Valsartan	Unknown	2 mg/kg	Oral
Subject	Valsartan	Unknown	4 mg/kg	Oral