Heart FailurePhase 2/3LENA-WP09NCT02652741
Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease
A Phase 2/3 study testing Enalapril Orodispersible Minitablet in people with Heart Failure and Congenital Heart Disease, run by Ethicare GmbH at 6 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Heart Failure, Congenital Heart Disease
- What is being tested?
- Enalapril Orodispersible Minitablet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Netherlands2 sites
Sophia Children's Hospital, Erasmus MC
Rotterdam, 3015 CN
Michiel Dalinghaus, MD,PhD, +3110-7040704, m.dalinghaus@erasmusmc.nl
Tjitske van der Zanden, +3110-7040704, t.vanderzanden@erasmusmc.nl
Wilhelmina Children's Hospital, University Medical Center Utrecht
Utrecht, 3584 CX
J.M.P. Breur J. Breur, MD,PhD, + 31 8875 540 02, h.breur@umcutrecht.nl
J.M.P. J. Breur, MD,PhD
Austria1 site
Medical University of Vienna
Vienna, 1090
Christoph Male, MD,PhD, + 43 1 40400 32320, christoph.male@meduniwien.ac.at
Vanessa Swoboda, MD, + 43 1 40400 32320, v.swoboda@live.at
Hungary1 site
Hungarian Paediatric Heart Centre, Göttsegen Gyorgy Hungarian Institute of Cardiology
Budapest, 1095
Andras Szatmari, Prof,MD,PhD, +36 1 215 1220, szatmari@kardio.hu
Laszlo Ablonczy, MD, +36 1 215 1220, ablonczyl@gmail.com
Serbia1 site
Univerzitetska Dečja Klinika
Belgrade, 11129
Milica Bajcetic, Prof,MD,PhD, 38 1112060716, milica.bajcetic@udk.bg.ac.rs
Ida Jovanovic, Prof,MD,PhD, 38 1112060716, idaj@rcub.bg.ac.rs
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Trust
London, WC1N 3JH
Michael Burch, Prof,MD,PhD, +44 020 7405 9200, michael.burch@gosh.nhs.uk
Michael Burch, Prof,MD,PhD
About this study
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.
Read the detailed description
This clinical trial is one of three clinical trials of the European Commission (FP7)-funded "LENA" (Labeling of Enalapril from Neonates to Adolescents) project: 50 children with heart failure due to congenital heart disease (LENA-Work Package (WP)09 Trial), and 50 children with heart failure due to dilated cardiomyopathy (LENA-WP08 Trial) get treated with an optimal dose of enalapril ODMTs for up to 8 weeks after thorough, individualised titration and get invited to join the 10 months Safety Follow-up Study (LENA-WP10 Trial).
In this WP09 Trial children from age of newborn to less than 6 years, naive to enalapril treatment or switched from an Angiotensin-Converting-Enzyme (ACE)-Inhibitor pre-treatment, receive an Initial Dose to investigate the reaction over 8 hours before a decision on the first dose level is made. Always up to 7 days later a next higher dose is given at the hospital, the patient is supervised for 4 and then always 2 hours before a decision on the prescribed dose for the next dosing period is made. In this study a target dose similar to the adult target dose (20 mg enalapril in a 70 year old adult result in 0.282 mg/kg/day enalapril) is defined. Enalapril ODMTs of 0.25 mg and 1 mg strength are available to allow for an individual dose titration scheme.
Weight-dependently, pharmacokinetic (PK) and pharmacodynamic (PD) data are collected once in a full PK/PD day over 12, respectively 6 hours, and single PK/PD samples at each Dose Titration Visit and each bi-weekly Study Control Visit until the Last Visit after 8 weeks of treatment. Blood pressure and renal monitoring is performed at each visit before deciding on the dose level for the next treatment period.
Pharmacogenomics and metabolomics exploratory studies are added as a sub-study to better understand the underlying disease, its progression as well as the impact of the ACE-inhibition on cardiac outcome and renal function.
- Conditions
- Heart Failure, Congenital Heart Disease
- Being tested
- Enalapril Orodispersible Minitablet
- Medical subject headings
- Heart Failure, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enalapril Orodispersible MinitabletDrug
Also called Enalapril ODMT
8-weeks treatment, open, uncontrolled, PK/PD, acceptability and palatability assessments and safety assessments after Enalapril intake in form of 0.25 mg or 1 mg ODMTs
| Study group | Role | What they receive |
|---|---|---|
| Drug administration | Experimental | Enalapril Orodispersible Minitablet (ODMT), 0.25 mg or 1 mg, administered 1x/day or 2x/day for up to 8 weeks Receives: Drug: Enalapril Orodispersible Minitablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Curve (AUC) of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in children with heart failure
Area under the Curve (AUC) of enalapril and enalaprilat are measured at first dose or at any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
Measured: 0 hours to 12 hours
Maximum Concentration (Cmax) of enalapril and its active metabolite
Maximum Concentration (Cmax) of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
Measured: 0 hours to 12 hours
Time to Maximum Concentration (Tmax) of enalapril and its active metabolite
Time to Maximum Concentration (Tmax) of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
Measured: 0 hours to 12 hours
Secondary outcomes (18)
AUC of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in two age-subsets of children with heart failure
AUC of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease in the age su-sets newborn to less than 1 year and 1 to less than 6 years; descriptive pharmacokinetic investigation
Measured: 0 hours to 12 hours
Cmax of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in two age-subsets of children with heart failure
Cmax of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease in the age su-sets newborn to less than 1 year and 1 to less than 6 years; descriptive pharmacokinetic investigation
Measured: 0 hours to 12 hours
Tmax of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in two age-subsets of children with heart failure
Tmax of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease in the age su-sets newborn to less than 1 year and 1 to less than 6 years; descriptive pharmacokinetic investigation
Measured: 0 hours to 12 hours
Renin
Renin as marker of the renin-angiotensin-aldosterone system at each study visit up to the end of treatment at 8 weeks; exploratory pharmacodynamic investigation
Measured: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Angiotensin 1
Angiotensin 1 as marker of the renin-angiotensin-aldosterone system at each study visit up to the end of treatment at 8 weeks; exploratory pharmacodynamic investigation
Measured: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Aldosterone
Aldosterone as marker of the renin-angiotensin-aldosterone system at each study visit up to the end of treatment at 8 weeks; exploratory pharmacodynamic investigation
Measured: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Plasma Renin Activity
Plasma Renin Activity as marker of the renin-angiotensin-aldosterone system at each study visit up to the end of treatment at 8 weeks; exploratory pharmacodynamic investigation
Measured: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Brain natriuretic peptides (BNPs).
Brain natriuretic peptides measurement as indicator of disease severity at every visit up to end of treatment at 8 weeks
Measured: At Screening Visit and then pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Acceptability of the ODMTs
Acceptability assessment according to an age-appropriate scale
Measured: Assessment time points: at Initial Dose Visit, at one Study Control Visit (day 14, 28 or 42), at Last Visit (day 56)
Palatability of the ODMTs
Palatability assessment according to an age-appropriate scale
Measured: Assessment time points: at Initial Dose Visit, at one Study Control Visit (day 14, 28 or 42), at Last Visit (day 56)
Blood pressure
Safety monitoring parameter to decide on next dose prescription level
Measured: Pre-dose at each Visit, over 8 hours at Initial Dose Visit, over 4 hours at First Titration Visit (day 3 to 7), for 2 hours after all following Titration Visits, pre-dose at all Study Control Visits (day 14, 28, 42), at last Visit (day 56)
Serum potassium
Renal monitoring parameter to decide on next dose prescription level
Measured: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Blood urea nitrogen (BUN)
Renal monitoring parameter to decide on next dose prescription level
Measured: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Creatinine
Renal monitoring parameter to decide on next dose prescription level
Measured: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Micro-albuminuria
Renal monitoring parameter to decide on next dose prescription level
Measured: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Shortening Fraction
Shortening Fraction in echocardiography
Measured: Assessment time points: at Screening Visit and at Last Visit (day 56)
Number of patients experiencing rehospitalisation due to heart failure
Number of patients experiencing rehospitalisation due to heart failure including the need for heart transplantation or the institution of mechanical circulatory support
Measured: During 8 weeks of treatment
Death due to worsening of the underlying disease
Death due to worsening of the underlying disease
Measured: During 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethicare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milica Bajcetic, Prof,MD,PhD, Study chair, Univerzitetska Dečja Klinika BelgradeIda Jovanovic, Prof,MD,PhD, Principal investigator, Univerzitetska Dečja Klinika BelgradeMichiel Dalinghaus, MD,PhD, Principal investigator, Sophia Children's Hospital, Erasmus MC RotterdamJ.M.P. J Breur, MD,PhD, Principal investigator, Wilhelmina Children's Hospital, University Medical Center UtrechtChristoph Male, Prof,MD,PhD, Principal investigator, Medical University of ViennaMichael Burch, Prof,MD,PhD, Principal investigator, Great Ormond Street Hospital for Children NHS Trust LondonAndrás Szatmári, Prof,MD,PhD, Principal investigator, Hungarian Paediatric Heart Centre, Göttsegen Gyorgy Hungarian Institute of Cardiology Budapest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652741
- Sponsor's protocol ID
- 2015-602295-02
- Other IDs
- 2015-002396-18, 2015
- Acronym
- LENA-WP09
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2016
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Serious Adverse Event information
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02652741
- Acronym / sponsor ID
- LENA-WP09 / 2015-602295-02
- Conditions
- Heart Failure, Congenital Heart Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ethicare GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is one of three clinical trials of the European Commission (FP7)-funded "LENA" (Labeling of Enalapril from Neonates to Adolescents) project: 50 children with heart failure due to congenital heart disease (LENA-Work Package (WP)09 Trial), and 50 children with heart failure due to dilated cardiomyopathy (LENA-WP08 Trial) get treated with an optimal dose of enalapril ODMTs for up to 8 weeks after thorough, individualised titration and get invited to join the 10 months Safety Follow-up Study (LENA-WP10 Trial).
In this WP09 Trial children from age of newborn to less than 6 years, naive to enalapril treatment or switched from an Angiotensin-Converting-Enzyme (ACE)-Inhibitor pre-treatment, receive an Initial Dose to investigate the reaction over 8 hours before a decision on the first dose level is made. Always up to 7 days later a next higher dose is given at the hospital, the patient is supervised for 4 and then always 2 hours before a decision on the prescribed dose for the next dosing period is made. In this study a target dose similar to the adult target dose (20 mg enalapril in a 70 year old adult result in 0.282 mg/kg/day enalapril) is defined. Enalapril ODMTs of 0.25 mg and 1 mg strength are available to allow for an individual dose titration scheme.
Weight-dependently, pharmacokinetic (PK) and pharmacodynamic (PD) data are collected once in a full PK/PD day over 12, respectively 6 hours, and single PK/PD samples at each Dose Titration Visit and each bi-weekly Study Control Visit until the Last Visit after 8 weeks of treatment. Blood pressure and renal monitoring is performed at each visit before deciding on the dose level for the next treatment period.
Pharmacogenomics and metabolomics exploratory studies are added as a sub-study to better understand the underlying disease, its progression as well as the impact of the ACE-inhibition on cardiac outcome and renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug administration | Experimental | Drug: Enalapril Orodispersible MinitabletEnalapril Orodispersible Minitablet (ODMT), 0.25 mg or 1 mg, administered 1x/day or 2x/day for up to 8 weeks |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enalapril Orodispersible MinitabletAlso: Enalapril ODMT8-weeks treatment, open, uncontrolled, PK/PD, acceptability and palatability assessments and safety assessments after Enalapril intake in form of 0.25 mg or 1 mg ODMTs | Drug | Drug administration |
Primary outcome
Area under the Curve (AUC) of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in children with heart failure
Time frame: 0 hours to 12 hours
Area under the Curve (AUC) of enalapril and enalaprilat are measured at first dose or at any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
Maximum Concentration (Cmax) of enalapril and its active metabolite
Time frame: 0 hours to 12 hours
Maximum Concentration (Cmax) of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
Time to Maximum Concentration (Tmax) of enalapril and its active metabolite
Time frame: 0 hours to 12 hours
Time to Maximum Concentration (Tmax) of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
18 secondary outcomes
AUC of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in two age-subsets of children with heart failure
Time frame: 0 hours to 12 hours
Cmax of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in two age-subsets of children with heart failure
Time frame: 0 hours to 12 hours
Tmax of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in two age-subsets of children with heart failure
Time frame: 0 hours to 12 hours
Renin
Time frame: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Angiotensin 1
Time frame: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Aldosterone
Time frame: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Plasma Renin Activity
Time frame: Pre-dose, 4 h post first dose, pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Brain natriuretic peptides (BNPs).
Time frame: At Screening Visit and then pre-dose at each Titration Visit and Study Control Visit (days 14, 28, 42) up to Last Visit (day 56)
Acceptability of the ODMTs
Time frame: Assessment time points: at Initial Dose Visit, at one Study Control Visit (day 14, 28 or 42), at Last Visit (day 56)
Palatability of the ODMTs
Time frame: Assessment time points: at Initial Dose Visit, at one Study Control Visit (day 14, 28 or 42), at Last Visit (day 56)
Blood pressure
Time frame: Pre-dose at each Visit, over 8 hours at Initial Dose Visit, over 4 hours at First Titration Visit (day 3 to 7), for 2 hours after all following Titration Visits, pre-dose at all Study Control Visits (day 14, 28, 42), at last Visit (day 56)
Serum potassium
Time frame: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Blood urea nitrogen (BUN)
Time frame: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Creatinine
Time frame: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Micro-albuminuria
Time frame: Pre-dose at each Visit: Screening Visit, Initial Dose Visit, all Titration Visits, all Study Control Visits (day 14, 28, 42) up to Last Visit (day 56)
Shortening Fraction
Time frame: Assessment time points: at Screening Visit and at Last Visit (day 56)
Number of patients experiencing rehospitalisation due to heart failure
Time frame: During 8 weeks of treatment
Death due to worsening of the underlying disease
Time frame: During 8 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Individual participant dataSharing planned: Yes. Serious Adverse Event information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milica Bajcetic, Prof,MD,PhD study chair
Univerzitetska Dečja Klinika Belgrade
Ida Jovanovic, Prof,MD,PhD principal investigator
Univerzitetska Dečja Klinika Belgrade
Michiel Dalinghaus, MD,PhD principal investigator
Sophia Children's Hospital, Erasmus MC Rotterdam
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Enalapril Orodispersible Minitablet in people with Heart Failure and Congenital Heart Disease, run by Ethicare GmbH at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Austria, Hungary, Serbia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Laeer, Prof,MD,PhD (+49 211 8110740, stephanie.laeer@uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Curve (AUC) of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in children with heart failure (time frame: 0 hours to 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.