FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRI

Phase 1

• Conditions: Heart Failure due to Dilated Cardiomyopathy and Congenital Heart Disease; MedDRA version: 18.1Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000004850; MedDRA version: 18.1Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002397-21-HU
• Lead Sponsor: Ethicare GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-29
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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