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    Summary
    EudraCT Number:2014-001905-42
    Sponsor's Protocol Code Number:LDLL600.201
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-001905-42
    A.3Full title of the trial
    Open-label Two-arm PD and PK Study of Landiolol in Patients with Tachycardic Atrial Fibrillation or Atrial Flutter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study to investigate pharmacodynamics, pharmacokinetic, safety and tolerability study of intravenous infusion of Landiolol hydrochloride (AOP LDLL600) in 20 Caucasian patients with tachycardic atrial fibrillation (AF) or atrial flutter (AFL) treated either according to "'Alternative"' or "'Conventional"' dosing scheme with a pilot phase and a planned randomized phase
    A.4.1Sponsor's protocol code numberLDLL600.201
    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 SponsorAOP Oprhan 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/ cityWien
    B.5.3.3Post code1160
    B.5.3.4CountryAustria
    B.5.4Telephone number00431503 72 44-40
    B.5.5Fax number00431503 72 44-65
    B.5.6E-mailmichaela.trebs@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 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 nameLandiolol hydrochloride lyophillized powder 600mg/50ml
    D.3.2Product code LDLL600
    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.3.9.3Other descriptive nameLANDIOLOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21964
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600 / 50
    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
    20 Caucasian patients with tachycardic atrial fibrillation (AF) or atrial flutter (AFL)
    E.1.1.1Medical condition in easily understood language
    20 Caucasian patients with tachycardic atrial fibrillation (AF) or atrial flutter (AFL)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10003663
    E.1.2Term Atrial flutter/ fibrillation
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to study PD of LDLL600 in Caucasian patients (pts) with tachycardic AF or AFL treated either according to "Alternative" or "Conventional" dosing scheme
    E.2.2Secondary objectives of the trial
    to study tolerability, safety and PK of the "Alternative" and "Conventional" LDLL600 dosing scheme in Caucasian pts with AF or AFL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. AF or AFL with ventricular rate between ≥100-200bpm/minute and clinical symptoms (including but not limited to palpitations, irregular pulse, fatigue, rapid heart beat, shortness of breath, dizziness, sweating)
    2. SBP ≥ 100 mmHg
    3. Able and willing to give informed consent
    4. Age ≥18
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. SBP <100 mmHg (measured with an automatic device in supine position)
    2. Sick sinus syndrome, AV block 2nd or 3rd degree
    3. Preexcitation syndromes
    4. Ventricular rate >200/min
    5. Acute coronary syndrome subjected to intervention (unstable angina,
    myocardial infarction)
    6. NYHA III and IV
    7. Cardiogenic shock or heart failure requiring inotropic agents or intubaiton
    8. Respiratory failure requiring intubation
    9. Pregnant or breast feeding patients
    10. History of hypersensitivity to any component of the study drug (e.g. landiolol,
    mannitol)
    11. Untreated pheochromocytoma
    12. Bronchospasm or asthma
    13. Ketoacidosis
    14. End stage disease
    15. Inability or unwillingness to provide informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is frequency of pts with successful HR control achieved and maintained during first 16 min (including) after continious IMP infusion start in one or the other dosage Group. Successful HR control is defined as achieving of HR <90 bpm or ≥20% reduction of HR from baseline (i.e. the last HR value available before IMP administration).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours
    E.5.2Secondary end point(s)
    Secondary endpoints:
    1. Frequency of pts with successful HR control at any measurement time point
    2. Frequency of pts with successful HR control achieved during first 16 min (including) after
    continuous infusion start and maintained up to infusion end
    3. Frequency of pts with successful HR control 60 min after continuous IMP infusion end
    4. Frequency of pts who converted to sinus rhythm evaluated at any measurement time point
    5. Time to successful HR control
    6. Time to conversion to sinus rhythm
    7. Incidence and severity/seriousness of adverse events
    8. Local tolerability over study course
    9. Average dose applied over course of the study and dose applied at each time-point
    10. Time-points when dose adjustment or infusion discontinuation is requested and dose administered at this time-points
    11. Pharmacokinetic parameters
    12. ECG parameters
    13. BP parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    "Conventional" dosing scheme
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    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) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 2014-08-06. 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 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 state20
    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
    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 Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
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