Brief Title
Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril
Official Title
Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril
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.
Detailed Description
This clinical trial is one of three clinical trials of the European Commission (FP7)-funded
"LENA" (Labeling of Enalapril from Neonates to Adolescents) project: 50 children with heart
failure due to dilated cardiomyopathy (LENA-Work Package (WP)08 Trial) and 50 children with
heart failure due to congenital heart disease (LENA-WP09 Trial) get treated with an optimal
dose of enalapril ODMTs for up to 8 weeks after thorough, individualised titration and get
invited to join this 10 months Safety Follow-up Study (LENA-WP10 Trial).
Reliable data on the long-term safety of enalapril in paediatric patients are currently not
available. By conducting this long-term Safety Follow-up Trial in children who received or
still receive enalapril Orodispersible Minitablets at the end of the 8-weeks PK/PD LENA-Work
Package (WP)08 (children with heart failure due to dilated cardiomyopathy) and LENA-WP09
(children with heart failure due to congenital heart disease) Trials using sensitive and
highly specific assay methodology, it will be possible to add to the generation of reliable
PK and PD data in the whole paediatric age range from birth to 12 years. In addition, this
follow-up study will allow to systematically collect follow-up information over 10 more
months, so in total 12 months, in paediatric patients under long-term enalapril ODMT
treatment and in paediatric patients who had received at least 3 days of ODMT treatment but
then stopped for any reason.
The End-of-study Visit of the WP08 and WP09 Trials is also the First Visit of the Follow-up
Study. Further Visits occur after 1 month, 4 months, 7 months and 10 months.
At each Visit blood pressure and renal monitoring as well as pharmacodynamic parameters and
adverse events are assessed. In children under ongoing enalapril ODMT treatment, single PK
sampling as well as acceptability and palatability assessments are made at each Visit.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Number of patients with Adverse Reactions
Secondary Outcome
Blood pressure
Condition
Heart Failure
Intervention
Enalapril Orodispersible Minitablet
Study Arms / Comparison Groups
Enalapril Orodispersible Minitablets
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
March 2016
Completion Date
April 2018
Primary Completion Date
April 2018
Eligibility 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 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.
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. However, adapted to the
health situation of the patient, the investigator will decide whether planned study
activities can be performed.
Gender
All
Ages
8 Weeks - 12 Years
Accepts Healthy Volunteers
No
Contacts
Saskia N. de Wildt, MD,PhD, +49 211 8110740, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02654678
Organization ID
2015-602295-03
Secondary IDs
2015-002397-21
Responsible Party
Sponsor
Study Sponsor
Ethicare GmbH
Study Sponsor
Saskia N. de Wildt, MD,PhD, Study Chair, Sophia Children's Hospital, Erasmus MC
Verification Date
January 2016