Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril (LENA-WP10)

NCT02654678 Phase 2/Phase 3 UNKNOWN

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.

Details

Lead sponsor	Ethicare GmbH
Phase	Phase 2/Phase 3
Status	UNKNOWN
Enrolment	100
Start date	2016-03
Completion	2018-04

Conditions

• Heart Failure
• Dilated Cardiomyopathy
• Congenital Heart Disease

Interventions

• Enalapril Orodispersible Minitablet

Primary outcomes

• Number of patients with Adverse Reactions — up to month 10
  Adverse Reaction definition according to European Directive 2001/20/EC, assessed at each Visit concerning intensity and causality

Countries

Austria, Hungary, Netherlands, Serbia, United Kingdom