Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
ID
Source
Brief title
Condition
- Other condition
- Congenital cardiac disorders
Synonym
Health condition
hartaandoeningen, myocardaandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Any adverse events.
Secondary outcome
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 including the need for heart
transplantation or the institution of mechanical circulatory support.
6. Death due to worsening of the underlying disease.
7. Echocardiography (Shortening Fraction).
Background summary
Enalapril maleate has established medical use having been marketed in Europe
since 1983. Its safety and efficacy in adults are therefore well understood,
although less so in paediatric patients since few clinical studies have been
conducted in this population. The European Medicines Agency Expert Group
Meeting on Paediatric Heart Failure considers enalapril a first-line treatment
for chronic heart failure in children (EMA, 2010a).
There is currently no licensed formulation of enalapril available in Europe
suitable for use in children with heart failure, resulting in the
administration of extemporaneous oral preparations. This study will enable the
development of a novel clinically relevant age-appropriate and acceptable
enalapril formulation, with improved method of administration and ease of
dosing compared to products currently available.
Study objective
Primary:
To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).
Secondary:
1. To describe the acceptability and palatability of enalapril ODMTs..
2. To collect additional information about pharmacokinetics and
pharmacodynamics of enalapril ODMTs during long term treatment.
Study design
Fase II/III Prospective open-label multi-centre extension safety study in
infants and children.
Intervention
nvt
Study burden and risks
nvt
Wiecherstr. 3
Haltern am See 45721
DE
Wiecherstr. 3
Haltern am See 45721
DE
Listed location countries
Age
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 for at least 3 days with enalapril Orodispersible Minitablets and are not anymore under ODMT treatment.
-Patient and/or parent(s)/legal representative provided written informed consent for participation in this long term follow-up study and assent is received from the patient according to national legislation and as far as achievable from the child.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002397-21-NL |
| CCMO | NL54931.078.15 |