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Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

NCT02652741 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-01-12

No results posted yet for this study

Summary

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

Conditions

Interventions

DRUG

Enalapril Orodispersible Minitablet

8-weeks treatment, open, uncontrolled, PK/PD, acceptability and palatability assessments and safety assessments after Enalapril intake in form of 0.25 mg or 1 mg ODMTs

Sponsors & Collaborators

  • Ethicare GmbH

    lead INDUSTRY

Principal Investigators

  • Milica Bajcetic, Prof,MD,PhD · Univerzitetska Dečja Klinika Belgrade

  • Ida Jovanovic, Prof,MD,PhD · Univerzitetska Dečja Klinika Belgrade

  • Michiel Dalinghaus, MD,PhD · Sophia Children's Hospital, Erasmus MC Rotterdam

  • J.M.P. J Breur, MD,PhD · Wilhelmina Children's Hospital, University Medical Center Utrecht

  • Christoph Male, Prof,MD,PhD · Medical University of Vienna

  • Michael Burch, Prof,MD,PhD · Great Ormond Street Hospital for Children NHS Trust London

  • András Szatmári, Prof,MD,PhD · Hungarian Paediatric Heart Centre, Göttsegen Gyorgy Hungarian Institute of Cardiology Budapest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Austria
  • Hungary
  • Netherlands
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02652741 on ClinicalTrials.gov