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Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy

NCT02652728 · 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 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, 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

Weight-dependent dose titration and long-term treatment scheme with enalapril ODMTs of 0.25 mg and 1 mg strength

Sponsors & Collaborators

  • Ethicare GmbH

    lead INDUSTRY

Principal Investigators

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

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

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

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

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

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
11 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 NCT02652728 on ClinicalTrials.gov