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Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

NCT02654678 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-01-13

No results posted yet for this study

Summary

Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12 years of age at recruitment into the preceding short-term pharmacokinetic (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as acceptability and palatability assessments in children still under enalapril Orodispersible Minitablet (ODMT) treatment.

Conditions

Interventions

DRUG

Enalapril Orodispersible Minitablet

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

Sponsors & Collaborators

  • Ethicare GmbH

    lead INDUSTRY

Principal Investigators

  • Saskia N. de Wildt, MD,PhD · Sophia Children's Hospital, Erasmus MC

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

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

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

  • 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Weeks
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-04-30
Completion
2018-04-30

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 NCT02654678 on ClinicalTrials.gov