drugset / Trial / NCT00433836

Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

NCT00433836

Phase 3 Completed 300 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

Timeline

Start
2007-01
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enalapril Other / unclassified 10 mg Oral
Comparator Enalapril Other / unclassified 20 mg Oral
Comparator Enalapril Other / unclassified 40 mg Oral
Subject Valsartan Small molecule 80 mg Oral
Subject Valsartan Small molecule 160 mg Oral
Subject Valsartan Small molecule 320 mg Oral

Indications