FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRI
- Conditions
- Heart Failure due to Dilated Cardiomyopathy and Congenital Heart DiseaseMedDRA version: 20.0Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000011531MedDRA version: 20.0Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 100000011725Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-002397-21-DE
- Lead Sponsor
- Ethicare GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 85
•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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).;Secondary Objective: 1.To describe the acceptability of ODMTs of enalapril.<br>2.To collect additional information about pharmacokinetics and pharmacodynamics of ODMTs of enalapril during long term treatment <br><br>;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 Outcome Measures
Name Time Method Secondary end point(s): 1.Blood pressure in paediatric patients under and after enalapril ODMT treatment.<br>2.Renal function in paediatric patients under and after enalapril ODMT treatment.<br>3.Exploratory pharmacokinetics and pharmacodynamics in paediatric patients under enalapril ODMT treatment.<br>4.Acceptability and palatability of the novel formulation in paediatric patients under enalapril ODMT treatment. <br>5.Rehospitalisation due to heart failure.<br>6.Death due to worsening of the underlying disease.<br><br>;Timepoint(s) of evaluation of this end point: Month 1, Month 4, Month 7 and Month 10