Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ethicare GmbH
• Treatments: Enalapril; Enalaprilat

Criteria

Inclusion Criteria:

Patients fulfilling the following Inclusion Criteria can be enrolled:

• Age from birth to less than 6 years.

• Male and female patients.

• Weight greater than 2.5 kg.

• Diagnosis of heart failure due to congenital heart disease requiring after-load reduction by drug therapy.

• Subjects may be naïve to ACE-Inhibitors.

• Subjects already on ACE-Inhibitors willing to switch to enalapril Orodispersible Minitablets.

• Patient and/or parent(s)/legal representative provided written informed consent and assent from the patient according to national legislation and as far as achievable from the child.

Exclusion Criteria:

Patients fulfilling any of the following Exclusion Criteria cannot be enrolled into this trial:

• Neonates if born < 37 weeks of gestation.

• Severe heart failure and/or end stage heart failure precluding introduction or continuation of ACE-Inhibitor.

• Too low blood pressure, e.g. ˂P5

• Uncorrected primary obstructive valvular disease, or significant systemic ventricular outflow obstruction, dilated restrictive or hypertrophic cardiomyopathy.

• Uncorrected severe peripheral stenosis of large arteries including severe coarctation of the aorta.

• Severe renal impairment with serum creatinine >2x Upper Limit of Normal (ULN) (according to the hospital's test methodology)

• History of angioedema.

• Hypersensitivity to ACE-Inhibitors.

• Concommitant medication:

• Dual ACE-Inhibitor therapy

• Renin inhibitors

• Angiotensin II antagonists

• Non-Steroidal Anti-Inflammatory Drugs (including ibuprofen) except for aspirin and paracetamol

• Already enrolled in an interventional trial with an investigational drug, unless no interference with the current study can be shown.