CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Valsartan +2 moredrug
Likely dose
Valsartan 320mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01365481
NCT01365481Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, 18 Month Study to Evaluate the Long-term Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age With Hypertension and With or Without Chronic Kidney Disease

Novartis Pharmaceuticals·interventional·Posted Jun 3, 2011·Updated Jul 13, 2016

In Brief

A Phase 3 clinical trial evaluating Valsartan, amlodipine, and 1 other intervention for Hypertension and Chronic Kidney Disease. Completed, enrolled 150 participants across 28 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Chronic Kidney Disease
CountriesColombia, Finland, Germany, Guatemala, Philippines, Poland, Romania, Russia, Singapore, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.1 years ago

Interventions

Valsartandrug

week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily

amlodipinedrug

added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose

Hydrochlorothiazidedrug

added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose