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    Summary
    EudraCT Number:2012-002927-14
    Sponsor's Protocol Code Number:AGO/2012/004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-25
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-002927-14
    A.3Full title of the trial
    Dosistitratie van lisinopril bij kinderen van 1 tot 18 jaar met primaire of secundaire hypertensie
    Dosistitratie van lisinopril bij kinderen van 1 tot 18 jaar met primaire of secundaire hypertensie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label dosistitratie van lisinopril bij kinderen tussen 1 en 18 jaar met primaire of secundaire hypertensie
    Open label dosistitratie van lisinopril bij kinderen tussen 1 en 18 jaar met primaire of secundaire hypertensie
    A.4.1Sponsor's protocol code numberAGO/2012/004
    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 Ghent
    B.1.3.4CountryBelgium
    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 supportUniversity Ghent
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Ghent
    B.5.2Functional name of contact pointTrial Bureau
    B.5.3 Address:
    B.5.3.1Street AddressDe Pintelaan 185
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3293320500
    B.5.5Fax number3293320520
    B.5.6E-mailTrialbureau@uzgent.be
    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 Yes
    D.2.1.1.1Trade name Zestril-5
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameLisinopril
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLisinopril
    D.3.9.1CAS number 76547-98-3
    D.3.9.3Other descriptive nameLISINOPRIL ANHYDROUS
    D.3.9.4EV Substance CodeSUB23348
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Zestril-20
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameLisinopril
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLisinopril
    D.3.9.1CAS number 76547-98-3
    D.3.9.3Other descriptive nameLISINOPRIL ANHYDROUS
    D.3.9.4EV Substance CodeSUB23348
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Hypertensie
    Hypertensie
    E.1.1.1Medical condition in easily understood language
    Verhoogde bloeddruk
    Verhoogde bloeddruk
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020781
    E.1.2Term Hypertension malignant
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluatie van de werkzaamheid en veiligheid van lisinopril bij kinderen van 1 tot 18 jaar met zowel primaire of secundaire hypertensie
    Evaluatie van de werkzaamheid en veiligheid van lisinopril bij kinderen van 1 tot 18 jaar met zowel primaire of secundaire hypertensie
    E.2.2Secondary objectives of the trial
    - Dose-respons relatie
    - Farmacokinetiek
    - Veiligheid
    - Dose-respons relatie
    - Farmacokinetiek
    - Veiligheid
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ouders of voogd van het kind moeten vrijwillig het informed consent-formulier tekenen vooraleer de start van de studie.
    • Leeftijd tussen 1 en 18 jaar.
    • Systolische en/of diastolische bloeddruk (gemiddelde van 3 metingen bij de zittende patiënt) >95ste percentiele voor leeftijd, lengte en geslacht volgens ‘The fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents’4, bij een ambulante automatische bloeddrukcontrole.
    • Bij kinderen ouder dan 6 jaar is het mogelijk een 24 uurs bloeddrukmeting te verrichten en dient deze de diagnose hypertensie te bevestigen.
    • Diagnostische uitwerking van verhoogde bloeddruk kon geen reversibele oorzaak aanduiden
    • Ouders of voogd van het kind moeten vrijwillig het informed consent-formulier tekenen vooraleer de start van de studie.
    • Leeftijd tussen 1 en 18 jaar.
    • Systolische en/of diastolische bloeddruk (gemiddelde van 3 metingen bij de zittende patiënt) >95ste percentiele voor leeftijd, lengte en geslacht volgens ‘The fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents’4, bij een ambulante automatische bloeddrukcontrole.
    • Bij kinderen ouder dan 6 jaar is het mogelijk een 24 uurs bloeddrukmeting te verrichten en dient deze de diagnose hypertensie te bevestigen.
    • Diagnostische uitwerking van verhoogde bloeddruk kon geen reversibele oorzaak aanduiden
    E.4Principal exclusion criteria
    • Zwangerschap
    • Meisjes die seksueel actief zijn kunnen enkel in de studie geïncludeerd worden indien zij bereid zijn een adequate anticonceptie te gebruiken, tijdens en tot 30 dagen na de studie.
    • Afwijkingen in het labo voor de start van de studie:
    o Hyperkaliëmie (serumkalium>5.3mmol/L)
    o Hemoglobine <8g/dL
    o Aspartaat aminotransferase en alanine aminotransferase >3x’upper limit of normal’ (ULN)
    o Bilirubine >2xULN
    • Abnormaliteiten of ziekten in de mondholte die de vrijstelling of de absorptie van de medicatie zou kunnen beïnvloeden.
    • Gekende overgevoeligheid voor ACE-inhibitoren
    • Gekende lactose-intolerantie
    • Voorgeschiedenis van angio-oedeem
    • Unilaterale of bilaterale stenose van de arteria renalis
    • Hartfalen (NYHA klasse II-IV)
    • Coarctatio aortae in de voorgeschiedenis
    • Concomitante medicatie:
    o Andere geneesmiddelen die inwerken op het renine-angiotensine- aldosteron-systeem
    o Lithium
    o Kaliumsparende diuretica
    o Kaliumsuppletie
    o Niet-steroïdale anti-inflammatoire geneesmiddelen
    o Aspirine
    o Antidiabetische geneesmiddelen
    • Zwangerschap
    • Meisjes die seksueel actief zijn kunnen enkel in de studie geïncludeerd worden indien zij bereid zijn een adequate anticonceptie te gebruiken, tijdens en tot 30 dagen na de studie.
    • Afwijkingen in het labo voor de start van de studie:
    o Hyperkaliëmie (serumkalium>5.3mmol/L)
    o Hemoglobine <8g/dL
    o Aspartaat aminotransferase en alanine aminotransferase >3x’upper limit of normal’ (ULN)
    o Bilirubine >2xULN
    • Abnormaliteiten of ziekten in de mondholte die de vrijstelling of de absorptie van de medicatie zou kunnen beïnvloeden.
    • Gekende overgevoeligheid voor ACE-inhibitoren
    • Gekende lactose-intolerantie
    • Voorgeschiedenis van angio-oedeem
    • Unilaterale of bilaterale stenose van de arteria renalis
    • Hartfalen (NYHA klasse II-IV)
    • Coarctatio aortae in de voorgeschiedenis
    • Concomitante medicatie:
    o Andere geneesmiddelen die inwerken op het renine-angiotensine- aldosteron-systeem
    o Lithium
    o Kaliumsparende diuretica
    o Kaliumsuppletie
    o Niet-steroïdale anti-inflammatoire geneesmiddelen
    o Aspirine
    o Antidiabetische geneesmiddelen
    E.5 End points
    E.5.1Primary end point(s)
    - bloeddruk
    - bloeddruk
    E.5.1.1Timepoint(s) of evaluation of this end point
    om de 2 weken
    om de 2 weken
    E.5.2Secondary end point(s)
    - proteïnurie
    - lisinoprilconcentraties
    - proteïnurie
    - lisinoprilconcentraties
    E.5.2.1Timepoint(s) of evaluation of this end point
    - om de 2 weken
    - om de 2 weken
    - om de 2 weken
    - om de 2 weken
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    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.8.3 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 No
    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
    LVLS
    Laatste visite laatste patiënt
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 33
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    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
    Geen
    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 Decision2012-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-14
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