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Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

NCT01617681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2017-09-27

Study results available
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Summary

To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.

Conditions

  • Pediatric Hypertension With or Without CKD

Interventions

DRUG

VAL489

Valsartan 3mg/kg oral solution

DRUG

VAL489 matching placebo

Valsartan 3 mg/kg oral solution

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-08
Primary Completion
2017-01-24
Completion
2017-01-24

Countries

  • Belgium
  • Brazil
  • France
  • Germany
  • Guatemala
  • Hungary
  • Italy
  • Lithuania
  • Poland

Study Locations

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Entities

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 NCT01617681 on ClinicalTrials.gov