Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
11 April 2016 |
Main ID: |
EUCTR2015-002397-21-NL |
Date of registration:
|
12/10/2015 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL
|
Scientific title:
|
FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL - ENALONG |
Date of first enrolment:
|
04/12/2015 |
Target sample size:
|
100 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002397-21 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
Phase:
|
|
|
Countries of recruitment
|
Austria
|
Hungary
|
Netherlands
|
Serbia
|
United Kingdom
| | | |
Contacts
|
Name:
|
Lead Clinical Project Manager
|
Address:
|
Av St-Hubert 51
1970
Wezembeek-Oppem
Belgium |
Telephone:
|
003227843693 |
Email:
|
iklingmann@pharmaplex.be |
Affiliation:
|
Pharmaplex bvba |
|
Name:
|
Lead Clinical Project Manager
|
Address:
|
Av St-Hubert 51
1970
Wezembeek-Oppem
Belgium |
Telephone:
|
003227843693 |
Email:
|
iklingmann@pharmaplex.be |
Affiliation:
|
Pharmaplex bvba |
| |
Key inclusion & exclusion criteria
|
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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
|
Heart Failure due to Dilated Cardiomyopathy and Congenital Heart Disease MedDRA version: 18.1
Level: LLT
Classification code 10010495
Term: Congenital heart disease NOS
System Organ Class: 100000004850
MedDRA version: 18.1
Level: LLT
Classification code 10056419
Term: Dilated cardiomyopathy
System Organ Class: 100000004849
|
Intervention(s)
|
Product Name: Enalapril Orodispersible Minitablets (ODMT) Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: Enalapril Maleate CAS Number: 76095-16-4 Current Sponsor code: ENA10BA Other descriptive name: ENALAPRIL MALEATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-
Product Name: Enalapril Orodispersible Minitablet (ODMT) Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: enalapril maleate CAS Number: 76095-16-4 Current Sponsor code: ENA10BA Other descriptive name: ENALAPRIL MALEATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25-
|
Primary Outcome(s)
|
Main Objective: To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).
|
Secondary Objective: 1. To describe the acceptability of ODMTs of enalapril. 2. To collect additional information about pharmacokinetics and pharmacodynamics of ODMTs of enalapril during long term treatment
|
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(s)
|
Secondary end point(s): Blood pressure in paediatric patients under and after enalapril ODMT treatment.
Renal function in paediatric patients under and after enalapril ODMT treatment.
Exploratory pharmacokinetics and pharmacodynamics in paediatric patients under enalapril ODMT treatment.
Acceptability and palatability of the novel formulation in paediatric patients under enalapril ODMT treatment.
Rehospitalisation due to heart failure including the need for heart transplantation or the institution of mechanical circulatory support.
Death due to worsening of the underlying disease.
Echocardiography (Shortening Fraction)
|
Timepoint(s) of evaluation of this end point: Month 1, Month 4, Month 7 and Month 10
|
Secondary ID(s)
|
602295
|
2015-602295-03
|
2015-002397-21-HU
|
Source(s) of Monetary Support
|
European Commission FP7 grant agreement 602295
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|