Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

Phase 3 Completed 250 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

Timeline

Start: 2007-06
Primary completion: 2009-06
Completion: 2009-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enalapril	Other / unclassified	10 mg	Oral
Subject	Enalapril	Other / unclassified	20 mg	Oral
Subject	Enalapril	Other / unclassified	40 mg	Oral
Subject	Valsartan	Unknown	80 mg	Oral
Subject	Valsartan	Unknown	160 mg	Oral
Subject	Valsartan	Unknown	320 mg	Oral

Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

Summary

Timeline

Drugs

Indications