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

NCT01365481 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-07-13

Study results available
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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.

Conditions

Interventions

DRUG

Valsartan

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

DRUG

amlodipine

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

DRUG

Hydrochlorothiazide

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Colombia
  • Finland
  • Germany
  • Guatemala
  • Philippines
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01365481 on ClinicalTrials.gov