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

NCT02654678 | Unknown Phase 2 DMC

• 2 other identifiers: 2015-602295-032015-002397-21
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 6

Brief 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

Heart Failure; Dilated Cardiomyopathy; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients with Adverse Reactions

  Adverse Reaction definition according to European Directive 2001/20/EC, assessed at each Visit concerning intensity and causality

  up to month 10

Secondary Outcomes (15)

• Blood pressure

  At every Visit: (day 0, month 1, 4, 7, 10)

• Renin

  Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)

• Angiotensin 1

  Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)

• Aldosterone

  Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)

• Plasma Renin Activity

  Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)

Study Arms (1)

Enalapril Orodispersible Minitablets

EXPERIMENTAL

Individually adapted dose of enalapril consisting of 1 to maximum 4 enalapril ODMTs of 0.25 mg and/or 1 mg and/or other prescribed treatment of heart failure.

Drug: Enalapril Orodispersible Minitablet

Interventions

Enalapril Orodispersible Minitablet DRUG

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

Also known as: Enalapril ODMT

Enalapril Orodispersible Minitablets

Eligibility Criteria

• Age: 8 Weeks - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients from the WP08 and WP09 Trials who have been treated with enalapril Orodispersible Minitablets and are still under ODMT treatment.
• Patients from the WP08 and WP09 Trials who have been treated for at least 3 days with enalapril Orodispersible Minitablets and are no longer under ODMT treatment.
• Written informed consent from parent(s)/legal representative provided written informed consent for participation in this long term follow-up study and assent from the patient according to national legislation and as far as achievable from the child.

Sponsors & Collaborators

• Ethicare GmbH: lead

Study Sites (6)

Medical University of Vienna

Vienna, 1090, Austria

Location

Hungarian Paediatric Heart Centre,Göttsegen Gyorgy Hungarian Institute of Cardiology

Budapest, 1095, Hungary

Location

Sophia Children's Hospital Erasmus MC

Rotterdam, 3015 CN, Netherlands

Location

Wilhelmina Children's Hospital, University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Univerzitetska Dečja Klinika

Belgrade, 11129, Serbia

Location

Great Ormond Street Hospital for Children NHS Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Congenital Abnormalities

Study Officials

• Saskia N. de Wildt, MD,PhD

  Sophia Children's Hospital, Erasmus MC

  STUDY CHAIR

• Michiel Dalinghaus, MD,PhD

  Sophia Children's Hospital, Erasmus MC

  PRINCIPAL INVESTIGATOR

• J.M.P. J. Breur, MD,PhD

  Wilhelmina Children's Hospital, University Medical Center Utrecht

  PRINCIPAL INVESTIGATOR

• Ida Jovanovic, Prof,MD,PhD

  Univerzitetska Dečja Klinika Belgrade

  PRINCIPAL INVESTIGATOR

• Christoph Male, Prof,MD,PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Michael Burch, Prof,MD,PhD

  Great Ormond Street Hospital for Children NHS Trust London

  PRINCIPAL INVESTIGATOR

• András Szatmári, Prof,MD,PhD

  Hungarian Paediatric Heart Centre, Göttsegen Gyorgy Hungarian Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Laeer, Prof,MD,PhD

CONTACT

+49 211 8110740; Stephanie.Laeer@uni-duesseldorf.de

Ingrid Klingmann, MD,PhD

CONTACT

+32 2 784 3693; iklingmann@pharmaplex.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 13, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 13, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); SE (1); AU (1); NL (2); HU (1)