drugset / Trial / NCT01365481

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

NCT01365481

Phase 3 Completed 150 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.

Timeline

Start
2011-08
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Valsartan Small molecule 80 mg Oral
Subject Valsartan Small molecule 160 mg Oral
Subject Valsartan Small molecule 320 mg Oral
Background Amlodipine Other / unclassified
Background Hydrochlorothiazide Unknown