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    Summary
    EudraCT Number:2015-001129-17
    Sponsor's Protocol Code Number:LDLL300.301
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-05-15
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-001129-17
    A.3Full title of the trial
    A multicenter, open-label study to investigate the effectiveness and safety of AOP Landiolol in controlling supraventricular tachycardia in pediatric patients (LANDI-PED).
    Multizentrische, offene Studie zur Untersuchung der Wirksamkeit und Sicherheit von AOP Landiolol zur Regulierung supraventrikulärer Tachykardien bei pädiatrischen Patienten (LANDI-PED)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the effectiveness and safety of AOP Landiolol in controlling supraventricular tachycardia in children.
    Studie zur Untersuchung der Wirksamkeit und Sicherheit von AOP Landiolol zur Regulierung von schnellen Herzrhythmusstörungen bei Kindern.
    A.3.2Name or abbreviated title of the trial where available
    LANDI-PED
    A.4.1Sponsor's protocol code numberLDLL300.301
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/283/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAOP Orphan Pharmaceuticals AG
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAOP Orphan Pharmaceuticals AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOP Orphan Pharmaceuticals AG
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressWilhelminenstraße 91/II f
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1160
    B.5.3.4CountryAustria
    B.5.4Telephone number431503 72 4440
    B.5.5Fax number431503 72 4465
    B.5.6E-maillandi-ped@aoporphan.com
    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 RAPIBLOC 300 mg (the batch used in the trial will be Batch H101, not the national marketed product. It will only be used "Landiolol Lyo 300". The national approval is not yet granted, but the approval process is already finalized)
    D.2.1.1.2Name of the Marketing Authorisation holderAmomed Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameRAPIBLOC (Landiolol hydrochloride lyophilized powder 300 mg/50 ml)
    D.3.2Product code LDLL300
    D.3.4Pharmaceutical form Powder for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLandiolol Hydrochloride
    D.3.9.1CAS number 144481-98-1
    D.3.9.2Current sponsor codeLDLL300
    D.3.9.4EV Substance CodeSUB21964
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Supraventricular tachycardia in pediatric patients.
    Supraventrikuläre Tachykardie bei pädiatrischen Patienten.
    E.1.1.1Medical condition in easily understood language
    Supraventricular tachycardia in children.
    Schnelle Herzrhythmusstörungen bei Kindern.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003859
    E.1.2Term AV reentrant tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074640
    E.1.2Term Junctional ectopic tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042604
    E.1.2Term Supraventricular tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052350
    E.1.2Term Multifocal atrial tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003662
    E.1.2Term Atrial flutter
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040752
    E.1.2Term Sinus tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003857
    E.1.2Term AV nodal reentrant tachycardia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Landiolol in the pediatric population.
    Beurteilung des pharmakokinetischen (PK) und pharmakodynamischen (PD) Profils von Landiolol in der pädiatrischen Population
    E.2.2Secondary objectives of the trial
    - Controlling supraventricular tachyarrhythmias in the pediatric population.
    - Assessment of safety of LDLL300 in the pediatric population.
    - Dose-response assessment for LDLL300 in the pediatric population.
    - Kontrolle von supraventrikulären Tachyarrhythmien in der pädiatrischen Population
    - Beurteilung der Sicherheit von LDLL300 in der pädiatrischen Population
    - Beurteilung des Dosis-Wirkungsprofils von LDLL300 in der pädiatrischen Population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent/assent from parents/legal representative(s) and children, if applicable.
    2. Age: from birth to the day before the 18th birthday.
    3. Body weight at least 2.5 kg.
    4. Sustained supraventricular tachyarrhythmia for more than 1 min.
    5. Paroxysmal supraventricular tachycardia (AVRT, AVNRT), refractory to treatment with adenosine, adenosine treatment relapsers and patients with contraindications to adenosine or other forms of paroxysmal SVT not indicated for adenosine.
    1. Patienteneinwilligung von Eltern/ gesetzlichen Vertreter(n) und Kindern, falls zutreffend.
    2. Alter: von der Geburt bis zum Tag vor dem 18. Geburtstag.
    3. Körpergewicht mindestens 2,5 kg.
    4. Anhaltende supraventrikuläre Tachyarrhythmie für mehr als 1 min.
    5. Anfallsartige supraventrikuläre Thachykardie (AVRT, AVNRT),die nicht auf die Behandlung mit Adenosin anspricht, Rückfall nach Adenosin-Behandlung und Patienten mit Kontraindikationen zu Adenosin oder andere Formen von paroxysmalen SVT, für die Adenosin nicht angezeigt ist.
    E.4Principal exclusion criteria
    1. Acute cardiogenic shock.
    2. Severe, uncorrectable metabolic acidosis.
    3. Ventricular tachycardia.
    4. Sick sinus syndrome (if there is no possibility for cardiac pacing) or clinically significant bradycardia.
    5. Acute asthma.
    6. Known pulmonary hypertension
    7. Known stage 4 and 5 chronic renal disease (Table 7).
    8. Treatment with a β-blocker within 12 hours before LDLL300 infusion start.
    9. Treatment with any Class I, III, IV or V antiarrhythmic drugs within 24 hours before LDLL300 infusion start (with the exception of adenosine).
    10. AV block 2nd or 3rd degree (if there is no possibility for cardiac pacing).
    11. Clinically significant hypotension.
    12. Postmenstrual age (gestational age + chronological age) <37 weeks
    13. Untreated pheochromocytoma.
    14. End-stage disease.
    15. Pregnant or breast feeding patients.
    16. Known hypersensitivity to any component of the study medication (e.g. Landiolol, mannitol).
    17. Participation in a clinical study or exposure to any study medication within 28 days before LDLL300 infusion start, with the exception of LDLL300 (end-of-study visit completed).
    18. Decompensated heart failure
    1. Akuter kardiogener Schock.
    2. Schwere, unkorrigierbare metabolische Acidosis.
    3. Ventrikuläre Tachykardie.
    4. Sick-Sinus-Syndrom (wenn es keine Möglichkeit für einen Herzschrittmacher gibt) oder klinisch signifikante Bradykardie.
    5. Akutes Asthma.
    6. Bekannter Lungenhochdruck
    7. Bekannte chronische Nierenerkrankung Stadium 4 und 5.
    8. Behandlung mit einem β-Blocker innerhalb 24h vor LDLL300 Infusionsbeginn.
    9. Behandlung mit irgendwelchen Klasse I, III, IV oder V antiarrhythmischen Medikamenten innerhalb von 24h vor IMP Infusionsbeginn (mit Ausnahme von Adenosin).
    10. AV block 2. oder 3. Grad (wenn es keine Möglichkeit für Herz-Schrittsteuerung gibt).
    11. Klinisch signifikante Hypotonie.
    12. Postmenstruelles Alter (Gestationsalter + Lebensalter) < 37 Wochen.
    13. Unbehandeltes Phäochromozytom.
    14. Krankheit im End-Stadium.
    15. Schwangere oder Stillende Patientinnen.
    16. Bekannte Hypersensitivität auf eine Komponente der Studienmedikation (z.B. Landiolol, Mannitol).
    17. Teilnahme an einer klinischen Studie oder Belastung mit einer Studienmedikation innerhalb von 28 Tagen vor IMP Infusionsstart, mit Ausnahme von LDLL300 (End-of-study Visit completed).
    18. Dekompensierte Herzinsuffizienz
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients converting to normal sinus rhythm (cardioversion) within 3.5 hours (210 min) of the commencement of the IMP infusion.
    Anteil der Patienten, die innerhalb von 3,5 Stunden (210 min) nach Beginn der IMP Infusion zu einem normalen Sinusrhythmus zurückkehren (Kardioversion).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3.5 hours (210 min)
    3,5 Stunden (210 min)
    E.5.2Secondary end point(s)
    - Relative and cumulative improvement rates (at least 20% reduction from baseline HR) at each dosing level (before increase of treatment dose).
    - Relative and cumulative non-response* rates at each dosing level.
    - Percent change in HR from baseline at each time point.
    - Relationship between change in heart rate from baseline and patient’s age.
    - Percentage of patients showing sustained restoration of sinus rhythm for more than 24 hours and 1 week after LDLL300 infusion end.
    - Percentage of patients for whom the infusion period was prolonged and duration of prolongation.
    - Percentage of patients achieving either SR conversion or HR control at any time during the prolongation period.
    - Time from start of LDLL300 infusion until 20% reduction of HR is achieved.
    - Time from start of LDLL300 infusion until conversion to normal sinus rhythm is achieved.
    *Non-responders” are treated patients who have no HR response (≥ 20% reduction of HR from baseline) and/or no conversion to normal sinus rhythm.

    Secondary pharmacokinetics endpoints:
    - PK variables including at least t1/2, AUC, volume of distribution, and total body clearance will be calculated using concentration collected during and after LDLL300 infusion end.

    Secondary safety endpoints:
    - Incidence and severity/seriousness of adverse events (AE).
    - Need for LDLL300 infusion end or dose reduction due to safety reasons (i.e. percentage of patients requiring LDLL300 infusion end or dose reduction due to AE(s) related to IMP).
    - Relative und kumulative Verbesserungsrate (min. 20% Reduktion von Baseline HR) bei jeder Dosisstufe (vor Erhöhung der Behandlungsdosis)
    - Relative und kumulative non-response* Rate bei jeder Dosisstufe.
    - Prozentuelle Änderung der HR von Baseline zu jedem Zeitpunkt.
    - Zusammenhang zwischen der Änderung der Herzrate von Baseline und Patientenalter.
    - Anteil der Patienten, die eine bleibende Wiederherstellung des Sinusrhythmus für mehr als 24 Stunden und 1 Woche nach LDLL300 Infusionsende haben.
    - Anteil der Patienten für welche die Infusionsdauer verlängert wurde und die Dauer der Verlängerung
    - Anteil der Patienten, die entweder SR-Wiederherstellung oder HR Kontrolle zu irgendeinem Zeitpunkt während der Verlängerungsperiode erreicht haben.
    - Zeit von Start der LDLL300 Infusion bis zum Erreichen von 20% Reduktion der HR
    - Zeit von Start der LDLL300 Infusion bis zur Rückkehr zu normalem Sinus Rhythmus.
    *Non-responders" sind behandelte Patienten, die kein HR-Ansprechen haben (≥ 20% Reduktion der HR von Baseline) und/ oder keine Rückkehr zum normalen Sinusrhythmus haben.

    Sekundäre pharmakokinetische Endpunkte:
    - PK Variablen, die zumindest t1/2, AUC, Verteilungsvolumen und Gesamtkörper-clearance beinhalten, werden berechnet unter Verwendung der Konzentration, die während und nach LDLL300 Infusionsende gesammelt wurde

    Sekundäre Sicherheits-Endpunkte:
    - Vorkommen und die Schwere/ das Ausmaß von Unerwünschten Ereignissen (AE)
    - Erfordernis für LDLL300 Infusionsende oder Dosis-Reduktion aufgrund von Sicherheitsgründen (z.B. Anteil von Patienten, die LDLL300 Infusionsende oder Dosis-Reduktion wegen AE(s), die im Zusammenhang mit dem IMP stehen, brauchen)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week, 24 hrs
    1 Woche, 24 Std.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    unkontrolliert
    uncontrolled
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    LVLS
    Letzter Patient letzte Visite
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 120
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 10
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-05-15. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minor-aged subjects are planned at age from 0 years on.
    Minderjährige Patienten ab Geburt werden eingeschlossen.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    After end of treatment, the registered study site will be the first contact for the study participants and the patients will be treated during the routine process.
    Nach Beendigung der Studienteilnahme fungiert das gemeldete Prüfzentrum als 1. unmittelbarer Ansprechpartner für die PrüfungsteilnehmerInnen und die Patienten werden routinemäßig weiterbehandelt.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation OKIDS GmbH
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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