Heart Failure due to Dilated Cardiomyopathy and Congenital Heart Disease MedDRA version: 18.1 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS System Organ Class: 100000004850 MedDRA version: 18.1 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 100000004849
Conditions
Sponsors
Ethicare GmbH
Eligibility
Sex/Gender
All
Inclusion 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: 100 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).;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 ;Primary end point(s): Any adverse events. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Germany, Hungary, Netherlands, Serbia, United Kingdom
Contacts
Public ContactLead Clinical Project Manager
Pharmaplex bvba
Outcome results
None listed