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    Summary
    EudraCT Number:2013-001189-40
    Sponsor's Protocol Code Number:3
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedEstonia - SAM
    A.2EudraCT number2013-001189-40
    A.3Full title of the trial
    PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE
    SUUKAUDSE SPIRONOLAKTOONI FARMAKOKINEETIKA KUNI 2- AASTASTEL LASTEL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE
    SUUKAUDSE SPIRONOLAKTOONI FARMAKOKINEETIKA KUNI 2- AASTASTEL LASTEL
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics of spironolactone in children
    A.4.1Sponsor's protocol code number3
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Tartu
    B.1.3.4CountryEstonia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEstonian Science Foundation
    B.4.2CountryEstonia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTartu University Hospital, Childrens Clinic
    B.5.2Functional name of contact pointNeonatal ward
    B.5.3 Address:
    B.5.3.1Street AddressLunini 6
    B.5.3.2Town/ cityTartu
    B.5.3.3Post code51014
    B.5.3.4CountryEstonia
    B.5.4Telephone number+3725088878
    B.5.5Fax number+3725088878
    B.5.6E-mailheili.varendi@kliinikum.ee
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSpironolactonum micronisatum
    D.3.2Product code Spironolactonum micronisatum
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSpironolactonum
    D.3.9.3Other descriptive nameSPIRONOLACTONE
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cardiac failure, ascites and/or oedema
    südamepuudulikkus, tursed, astsiit
    E.1.1.1Medical condition in easily understood language
    cardiac failure, ascites and/or oedema
    südamepuudulikkus, tursed, astsiit
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10010394
    E.1.2Term Congenital cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10049630
    E.1.2Term Oedema due to renal disease
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10030103
    E.1.2Term Oedema generalized
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10003445
    E.1.2Term Ascites
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aims of the study
    - To describe PK profile of spironolactone in children up to two years of age with cardiac failure, ascites and/or oedema
    - To describe PK parameters of the main metabolites of spironolactone (7 alpha- thiomethylspironolactone and canrenone) in children up to two years of age
    - To correlate plasma PK profiles of spironolactone with predefined clinical efficacy measures in children up to two years of age with cardiac failure, ascites and/or oedema

    E.2.2Secondary objectives of the trial
    • To describe PK profile of spironolactone in children up to two years of age with cardiac failure, ascites and/or oedema;
    • To describe PK parameters of the main metabolites of spironolactone (7 alpha- thiomethylspironolactone and canrenone) in children up to two years of age;
    • To correlate plasma PK profiles of spironolactone with predefined clinical efficacy measures in children up to two years of age with cardiac failure, ascites and/or oedema;
    • To assess the safety profiles of oral spironolactone in children up to two years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Age 35+0 weeks of gestation up to two years of age
    2. Clinical need for spironolactone treatment due to heart failure, ascites, oedema
    3. Clinical need for an arterial, central venous or venous catheter
    4. Admission to study units
    5. Informed consent by the parents or by the legitimate representative of the child.
    E.4Principal exclusion criteria
    1. Acute renal insufficiency, oligoanuria
    diuresis <0.5 ml/kg/h; creatinine >100 mcmol/L
    2. Addison's disease or other conditions associated with hyperkalemia
    3. Hyperkalemia >5.5 mmol/l
    4. Hyponatraemia <130.0 mmol/l
    5. Hypersensitivity to spironolactone
    6. Concomitant use of potassium sparing diuretics
    E.5 End points
    E.5.1Primary end point(s)
    • A noncompartmental model of disposition of spironolactone and its main metabolites
    o CL, Vd, AUC, Cmax, Tmax
    • A noncompartmental model of disposition of spironolactone and its main metabolites
    o CL, Vd, AUC, Cmax, Tmax
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples for spironolactone and main metabolites plasma concentration measurements will be collected before and in the following time-points after the study dose of the drug: 30 min, 60 min, 1,5h, 4h, 8h, 12h, 23h and also 46h and 72h after study dose if feasible or from the leftovers of regular blood analyses drawn after the 23 hour post dose.
    Blood samples for spironolactone and main metabolites plasma concentration measurements will be collected before and in the following time-points after the study dose of the drug: 30 min, 60 min, 1,5h, 4h, 8h, 12h, 23h and also 46h and 72h after study dose if feasible or from the leftovers of regular blood analyses drawn after the 23 hour post dose.
    E.5.2Secondary end point(s)
    NA
    Safety endpoints

    Specific safety end-points will not be applied as the treatment is clinically indicated and routinely used in this specific clinical setting. However, all participating patients will be subjects of multiparametric monitoring and all adverse effects will be recorded and documented during study period and 7 days thereafter (for details please see below and CRF).
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    7 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    7 days after study dose administration.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 27
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 9
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 9
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 9
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    lapsed
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children
    lapsed
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 27
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ei ole
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-28
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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