FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL

• Register: EUCTR
• Last refreshed on: 1 October 2018
• Main ID: EUCTR2015-002397-21-AT
• Date of registration: 19/10/2015
• Prospective Registration: Yes
• Primary sponsor: Ethicare GmbH
• Public title: FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL
• Scientific title: FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL - ENALONG
• Date of first enrolment: 17/11/2015
• Target sample size: 85
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002397-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Germany, Hungary, Netherlands, Serbia, United Kingdom

Contacts

• Name: Lead Clinical Project Manager
• Affiliation: Pharmaplex bvba

• Name: Lead Clinical Project Manager
• Affiliation: Pharmaplex bvba

Key inclusion & exclusion criteria

Inclusion criteria:
• 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 with at least 3 doses of enalapril Orodispersible Minitablets and are not anymore under ODMT treatment.
• Patient and/or parent(s)/legal guardian provided written informed consent for participation in this long term follow-up study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 85
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients who have been enrolled and treated in the WP08 or WP09 trials have fulfilled the respective in- and exclusion criteria of those protocols. As it is the aim of this Follow-up Study to observe the safety of all patients exposed to enalapril ODMT treatment, no additional exclusion criteria are defined in this protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Heart Failure due to Dilated Cardiomyopathy and Congenital Heart Disease
MedDRA version: 20.0 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS System Organ Class: 100000004850
MedDRA version: 20.0 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 100000004849

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: Enalapril Orodispersible Minitablets (ODMT)
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Enalapril Maleate
CAS Number: 76095-16-4
Current Sponsor code: ENA10BA
Other descriptive name: ENALAPRIL MALEATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: Enalapril Orodispersible Minitablet (ODMT)
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: enalapril maleate
CAS Number: 76095-16-4
Current Sponsor code: ENA10BA
Other descriptive name: ENALAPRIL MALEATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,25-

Primary Outcome(s)

Secondary Objective: 1. To describe the acceptability of ODMTs of enalapril.
2. To collect additional information about pharmacokinetics and pharmacodynamics of ODMTs of enalapril during long term treatment

Timepoint(s) of evaluation of this end point: during every visit, the doctor will ask patient and parents about any events. Parents are completing pt diary during the period between visits. Month 1, Month 4, Month 7 and Month 10

Main Objective: To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).

Primary end point(s): Any adverse events.

Secondary Outcome(s)

Secondary end point(s): 1. Blood pressure in paediatric patients under and after enalapril ODMT treatment.
2. Renal function in paediatric patients under and after enalapril ODMT treatment.
3. Exploratory pharmacokinetics and pharmacodynamics in paediatric patients under enalapril ODMT treatment.
4. Acceptability and palatability of the novel formulation in paediatric patients under enalapril ODMT treatment.
5. Rehospitalisation due to heart failure.
6. Death due to worsening of the underlying disease.

Timepoint(s) of evaluation of this end point: Month 1, Month 4, Month 7 and Month 10

Secondary ID(s)

2015-002397-21-HU

602295

2015-602295-03

Source(s) of Monetary Support

European Commission FP7 grant agreement 602295