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    Summary
    EudraCT Number:2018-002979-17
    Sponsor's Protocol Code Number:K620
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-002979-17
    A.3Full title of the trial
    Use of doxapram as a new antiarrhythmic drug for a specific therapy of atrial fibrillation
    Einsatz von Doxapram als neues Antiarrhythmikum für eine spezifische Vorhofflimmertherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of doxapram as a new antiarrhythmic drug for a specific therapy of atrial fibrillation
    Einsatz von Doxapram als neues Antiarrhythmikum für eine spezifische Vorhofflimmertherapie
    A.3.2Name or abbreviated title of the trial where available
    Doctos Trial (DOxapram Conversion TO Sinus rhythm study)
    A.4.1Sponsor's protocol code numberK620
    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 SponsorRuprecht-Karls University Heidelberg Medical Faculty, University Hospital
    B.1.3.4CountryGermany
    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 of Heidelberg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Heidelberg
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 410
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number00496221568740
    B.5.5Fax number00496221564642
    B.5.6E-mailWalter.Emil.Haefeli@med.uni-heidelberg.de
    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 Dopram®
    D.2.1.1.2Name of the Marketing Authorisation holderCARINOPHARM GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Paroxysmal or persistent, non-valvular, atrial fibrillation
    E.1.1.1Medical condition in easily understood language
    Paroxysmal or persistent, non-valvular, atrial fibrillation
    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 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 LLT
    E.1.2Classification code 10034039
    E.1.2Term Paroxysmal 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 LLT
    E.1.2Classification code 10071667
    E.1.2Term Persistent atrial fibrillation
    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
    Antiarrhythmic potential for cardioversion from AF to SR after i.v. administration of doxapram
    E.2.2Secondary objectives of the trial
    • Recommended i.v. doxapram dose for cardioversion
    • Time to cardioversion from AF to SR after i.v. doxapram administration
    • Time to recurrence of AF within 7 ± 2 d of cardioversion
    • Doxapram PK after i.v. administration of one or two equal consecutive bolus doses
    • Safety and tolerability of doxapram after i.v. administration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 – 80 years,
    2. Patient meets in-house eligibility criteria for non-emergent, electrical or pharmacological cardioversion (absence of AF-inducing medical conditions such as e.g. valvular disease, sufficient anticoagulation, and/or exclusion of cardiac thrombus),
    3. Available previous ECG in sinus rhythm to allow for an assessment of QT time,
    4. Ability to understand and willingness to comply with study interventions, and
    5. Voluntarily signed informed consent after full explanation of the study to the patient.
    E.4Principal exclusion criteria
    1. Any participation in a clinical drug trial within 5 times the documented terminal half-life of the respective active drug or if half-life is unknown within the last four weeks before inclusion,
    2. Any physical disorder as judged by the investigator that could interfere with the patient’s safety during the clinical trial or with the study objectives,
    3. Inability to communicate well with the investigator due to language problems or poor mental development,
    4. Pregnancy or lactation,
    5. Intake of antiarrhythmic agents as co-medication (Vaughan Williams classification), except class II beta-blockers, within less than 5 half-lives of the respective drug as related to planned exposure:
    class Ia: e.g. quinidine, ajmaline, procainamide, or disopyramide,
    class Ib: e.g. lidocaine, phenytoin, mexiletine, or tocainide,
    class Ic: e.g. encainide, flecainide, propafenone, or moricizine,
    class III: e.g. amiodarone, sotalol, ibutilide, dofetilide, dronedarone, or vernakalant,
    class IV: e.g. verapamil ordiltiazem,
    class V: e.g. adenosine, digoxin, or digitoxin,
    unclassified: ranolazine,
    6. Any adenosine like drugs (e.g. ticagrelor) within less than 5 half-lives of the respective drug,
    7. Any magnesium intake (> 500 mg) within 4 h of planned exposure, if magnesium has been applied within 24 h prior to planned exposure magnesium blood level must not higher than the upper limit of normal (+ 10%),
    8. Any theophylline intake within 3 d as related to planned exposure,
    9. Contraindication for doxapram use present such as
    a) known intolerance to doxapram,
    b) systolic blood pressure < 100 mmHg or > 170 mmHg,
    c) diastolic blood pressure < 60 mmHg or > 100 mmHg,
    d) Heart rate < 50 / min,
    e) acute coronary syndrome,
    f) decompensated heart failure or chronic heart failure (NYHA) class III or IV,
    g) hyperthyreodism,
    h) history of pheochromocytoma,
    i) impaired breathing function (due to a history of e.g. accidental injury, pneumothorax, pulmonary embolism, neuromuscular impairment, lung fibrosis, asthma, or other impairment of breathing),
    j) history of epilepsy or other convulsive disorders,
    k) history of cerebral injury, cerebral edema, cerebral ischemia or cerebral bleeding,
    10. Any emergency situation which requires emergency treatment,
    11. Any immediate need of sympathomimetics, monoaminooxidase inhibitors, halothane, isoflurane, enflurane, theophylline,
    12. Hemoglobin < 10 g/dl,
    13. Known channelopathy, or
    14. Signs of long QT syndrome (male participants with QTc > 430 ms, female participants with QTc > 450ms) or short QT syndrome in an ECG in sinus rhythm recorded.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients with cardioversion from AF to SR (yes/no) within 6 h after i.v. doxapram as measured by 12-lead ECG.
    For the primary objective SR is defined as any rhythm originating in the atrium, the junctional area or the His bundle, which is not atrial fibrillation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 h (i.v.) after application depending on the route of administration.
    E.5.2Secondary end point(s)
    • Time to cardioversion from AF to SR as documented by 12-lead ECG
    • Persistence of rhythm over 7 ± 2 d of cardioversion as measured by 7-d Holter ECG
    • Doxapram PK: plasma concentrations of doxapram and derived PK parameters (e.g. highest concentration (Cmax), time to highest concentration (Tmax), area under the curve from 0 to 6 h (AUC0-6) after i.v. administration, and half-life (t1/2).
    • AEs as assessed by open questions and predefined procedures including assessment of well-being, physical examination, vital signs, and laboratory measurements.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From exposure till end of study
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Efficacy study in a new indication
    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 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.8.3 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 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
    End of trial is defined as the date of database closure, which must occur not later than 4 months after the last patient last visit.
    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 months9
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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)
    No post trial treatment is planned.
    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 Decision2018-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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