A Phase 2/3 interventional study of Enalapril Orodispersible Minitablet in Heart Failure, Dilated Cardiomyopathy and Congenital Heart Disease, sponsored by Ethicare GmbH. Status unknown at 6 sites in 5 countries. Open to participants aged 8 Weeks to 12 Years. Per ClinicalTrials.gov, last updated 2016-01-13.
Sponsored by Ethicare GmbH · Phase 2/3, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Ethicare GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Drug: Enalapril Orodispersible Minitablet
Weight-dependent long-term treatment scheme with enalapril ODMTs of 0.25 and/or 1 mg strength
Also known as: Enalapril ODMT
Number of patients with Adverse Reactions
Adverse Reaction definition according to European Directive 2001/20/EC, assessed at each Visit concerning intensity and causality
Time frame: up to month 10
Blood pressure
Measurement pre-dose after 5 minutes at rest at every Visit up to end of treatment at Month 10
Time frame: At every Visit: (day 0, month 1, 4, 7, 10)
Renin
Renin to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Angiotensin 1
Angiotensin 1to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Aldosterone
Aldosterone to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Plasma Renin Activity
Plasma renin activity to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Creatinine
Creatinine for renal monitoring measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Urea nitrogen
Urea nitrogen for renal monitoring measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Serum potassium
Serum potassium for renal monitoring measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Brain-Natriuretic-Peptides (BNP)
BNP measured at every visit up to end of treatment at Month 10 to observe disease severity
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Micro-albuminuria
Measurement of micro-albuminuria for renal monitoring measured at every Visit up to end of treatment at Month 10
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Clinical haematology
Assessment at First and Last Study Visit at the end of treatment at Month 10
Time frame: Day 0 and Month 10
ECG
Assessment at First and Last Study Visit at the end of treatment at Month 10
Time frame: Day 0 and Month 10
Plasma concentration of enalapril and its active metabolite enalaprilat under long-term treatment
At each Visit in children under enalapril ODMT treatment a single blood sample will be collected to measure the enalapril and enalaprilat plasma levels during long-term treatment; population-kinetic investigation
Time frame: Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)
Acceptability assessment of enalapril ODMTs
Acceptability assessment at each Visit up to end of treatment at 10 months in children under enalapril ODMT treatment according to an age-appropriate scale
Time frame: At each Visit: (day 0, month 1, 4, 7, 10)
Palatability assessment of enalapril ODMTs
Palatability assessment at each Visit up to end of treatment at Month 10 in children under enalapril ODMT treatment according to an age-appropriate scale
Time frame: At each Visit: (day 0, month 1, 4, 7, 10)
Plan to share: Yes — Serious Adverse Event information
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This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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