Main
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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:
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EUCTR |
Last refreshed on:
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1 October 2018 |
Main ID: |
EUCTR2015-002335-17-AT |
Date of registration:
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19/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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ORODISPERSIBLE MINITABLETS OF ENALAPRIL IN CHILDREN WITH HEART
FAILURE DUE TO DILATED CARDIOMYOPATHY
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Scientific title:
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ORODISPERSIBLE MINITABLETS OF ENALAPRIL IN CHILDREN WITH HEART
FAILURE DUE TO DILATED CARDIOMYOPATHY - ENADCM |
Date of first enrolment:
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17/11/2015 |
Target sample size:
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25 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002335-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Group 1: ACEI-pretreated patients. Group B: ACEI-naive patients If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Germany
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Hungary
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Netherlands
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Serbia
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United Kingdom
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Contacts
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Name:
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Lead Clinical Project Manager
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Address:
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Av St-Hubert 51
1970
Wezembeek-Oppem
Belgium |
Telephone:
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003227843693 |
Email:
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iklingmann@pharmaplex.be |
Affiliation:
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Pharmaplex bvba |
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Name:
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Lead Clinical Project Manager
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Address:
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Av St-Hubert 51
1970
Wezembeek-Oppem
Belgium |
Telephone:
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003227843693 |
Email:
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iklingmann@pharmaplex.be |
Affiliation:
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Pharmaplex bvba |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Age 1 month to <12 years.
• Male and female patients.
• Diagnosis of DCM presenting with LV end-diastolic dimension ? P95 and/or LV shortening fraction ? 25% in patients, resulting from different types of underlying cardiac disease with signs of decreased systolic LV function, and without ACE Inhibitor treatment; patients with ACE Inhibitor pre-treatment must have documented evidence of having fulfilled these criteria before start of the ACE Inhibitor therapy.
• Subjects may be naïve to ACEI.
• Subjects already on ACEI willing to switch to enalapril Orodispersable Minitablets.
• Patient and/or parent(s)/legal representative provided written informed consent.
Permitted:
Other CHF medications will be allowed, at the discretion of the treating physician. These include but are not limited to diuretics, beta-blockers, digoxin, mineralocorticoid receptor antagonist, aspirin.
Are the trial subjects under 18? yes Number of subjects for this age range: 25 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: • Severe HF and/or end stage heart failure requiring ICU support precluding introduction or continuation of ACEI.
• Too low blood pressure, e.g. below P5
• Restrictive and hypertrophic cardiomyopathies.
• Obstructive valvular disease (peak echocardiographic gradient more than 30 mm Hg).
• Uncorrected severe peripheral stenosis of large arteries including severe coarctation of the aorta.
• Severe renal impairment with serum creatinine >2x ULN (Upper Limit of Normal) according to the hospital's test methodology).
• History of Angioedema.
• Hypersensitivity to ACEI.
• Concomittant medication:
o Dual ACEI therapy
o Renin inhibitors
o Angiotensin II antagonists
o NSAIDs except acetylsalicylic acid only for antiplatelet therapy
• Already enrolled in interventional trial with an investigational drug, unless no interference with current study can be shown.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Heart Failure due to Dilated Cardiomyopathy MedDRA version: 20.0
Level: LLT
Classification code 10056419
Term: Dilated cardiomyopathy
System Organ Class: 100000004849
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Intervention(s)
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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-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: PK/PD profile sampling timepoint: Visit day 1: pre-dose, 0h, 2, 4, 6, 8, 12 hours
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Main Objective: To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.
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Primary end point(s): The bioavailability of enalapril and its active metabolite enalaprilat in the paediatric population (AUC from 0 to time of last sampling point, Cmax and Tmax); descriptive pharmacokinetic investigation.
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Secondary Objective: 1. To demonstrate safety, in particular renal safety, of enalapril ODMTs in children with DCM. 2. To characterise the dose/safety relationship from a starting dose to an optimal maintenance dose. 3. To explore the dose exposure/response relationship with pharmacodynamic parameters in the paediatric population with DCM. 4. To investigate the Shortening Fraction (SF) of the heart muscle by echocardiography. 5. To investigate the acceptability and palatability of enalapril ODMTs in the paediatric population with DCM.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Biochemistry, Urine and BNP collected during each visit in the hospital to ensure renal function.
PK and PD 1 sample collected during each visit, unless the patient terminated use of the IMP, then only PD sample is collected.
Accepútability and Palatability questionnaire is completed during initial visit, once stable dose is reached and during end of study visit.
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Secondary end point(s): 1. The bioavailability of enalapril and its active metabolite enalaprilat in the different age subsets (1 months to ?12 months, 12 months to ?6 years, 6 years to ?12 years) of the paediatric population (AUC from 0 to time of last sampling point, Cmax and Tmax); descriptive pharmacokinetic investigation.
2. Markers of the renin-angiotensin-aldosterone system as exploratory pharmacodynamic investigation.
3. Brain natriuretic peptides (BNPs).
4. Acceptability and palatability of the novel formulation.
5. Safety parameters including blood pressure and renal function.
6. Echocardiography (Shortening Fraction)
7. Rehospitalisation due to heart failure.
8. Death due to worsening of the underlying disease
9. Pharmacodynamic and efficacy endpoints analysis to differentiate high and low output disease
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Secondary ID(s)
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2015-002335-17-HU
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2015-602295-01
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602295
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Source(s) of Monetary Support
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European Commission FP7 grant agreement 602295
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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