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    Summary
    EudraCT Number:2010-018976-25
    Sponsor's Protocol Code Number:DRONE_L_05006
    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:2010-06-10
    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 number2010-018976-25
    A.3Full title of the trial
    An open label non-controlled trial to evaluate the effect of dronedarone (Multaq® 400 mg BID) on the quality of life in patiënts with a history of, or current non-permanent atrial fibrillation (AF)
    A.3.2Name or abbreviated title of the trial where available
    HEMERA
    A.4.1Sponsor's protocol code numberDRONE_L_05006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis Belgium
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Multaq 400 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMultaq 400 mg film-coated tablets
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Non permanent Atrial fibrillation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the change in quality of life defined as change in SF-36 Physical Component Summary Scale Score after 3 months of treatment
    E.2.2Secondary objectives of the trial
    • To evaluate the change in quality of life defined as change in SF-36 Physical Component Summary Scale Score after 6 months of treatment
    • To evaluate the change in quality of life defined as change in the EQ-5D Descriptive System Score, EQ-5D Visual Analogue Scale Score and SF-36 Mental Component Summary Scale Score after 3 and 6 months of treatment
    • To evaluate AF recurrence
    • To assess safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinically stable patients with a history of, or current, symptomatic non-permanent Atrial Fibrillation (AF) in whom anti-arrhythmic treatment is indicated
    • Patients able to understand the patient information leaflet and sign the Informed Consent form for this study protocol
    • Patients aged ≥ 18 years
    • Documented AF within the last 6 months prior to inclusion or at the time of inclusion
    • Documented sinus rhythm within the last 6 months prior to inclusion or at the time of inclusion
    E.4Principal exclusion criteria
    Criteria stated in the Summary of Product Characteristics
    ------------------------------------------------------------------------
    • Hypersensitivity to the active substance or to any of the excipients
    • Second- or third-degree atrio-ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
    • Bradycardia < 50 beats per minute (bpm)
    • Patients in unstable hemodynamic conditions including patients with symptoms of heart failure at rest or with minimal exertion (corresponding to NYHA class IV and unstable class III patients)
    • Co-administration with potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone, and ritonavir
    • Usage of medicinal products inducing torsade de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine, and certain oral macrolides, class I and III anti-arrhythmics
    • QTc Bazett interval ≥ 500 milliseconds
    • Severe hepatic impairment
    • Severe renal impairment (CrCl < 30 ml/min)
    • Left Ventricular Ejection Fraction (LVEF) < 35%
    • Stable patients with recent (1 to 3 months) NYHA class III heart failure
    • Electrolytes imbalance; hypokalemia, serum potassium (< 3.5 mmol/l or > 5.5 mmol/l), or magnesium imbalance must be corrected before inclusion
    • Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose mal-absorption
    • Treatment with other class I or III anti-arrhythmic drugs which cannot be discontinued
    • Pregnancy
    • Breastfeeding women

    General Criteria
    --------------------
    • Clinically relevant gastro-intestinal, psychiatric, or neurological disease
    • Women of childbearing potential without adequate birth control (e.g. oral contraception or intra-uterine device [IUD]), not menopaused, not sterile, or not hysterectomized
    • Participation in the preceding 2 months or current participation in another clinical trial with an investigational (under development) drug, or with an investigational device
    • Inability to follow the protocol requirements
    • Patient unable or unwilling to complete the Quality of Life questionnaires
    • Patient unable or unwilling to participate in the Holter monitoring procedure
    • Any non-cardiovascular illness or disorder that could preclude participation or severely limit survival

    Criteria linked to cardiac condition
    -------------------------------------------
    • Patients with asymptomatic Atrial Fibrillation
    • Patients unwilling to start with or change anti-arrhythmic therapy
    • Patients already treated with dronedarone during the preceding 6 months
    • Planned major non-cardiac or cardiac surgery, or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or on urgent cardiac transplantation list
    • Documented AF episode motivating inclusion in the study after an acute condition known to cause AF (e.g. alcohol intake, thyrotoxicosis, acute infection, pericarditis, pulmonary embolism, cardiac surgery)
    •Patients known to have chronic AF defined as permanent AF for more than 6 months
    • Ablated patients
    • Unstable angina pectoris (ischemic symptoms during the last 7 days), or recent myocardial infarction (< 6 weeks)
    • First-degree family history of sudden cardiac death below age of 50 years in the absence of coronary heart disease
    • Ongoing potentially dangerous symptoms when in AF, such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator
    • Single chamber ventricular pacemaker
    • Wolff-Parkinson-White Syndrome

    Criteria linked to Concomitant Medication
    ----------------------------------------------------
    • Patients in whom contraindicated concomitant treatment is mandatory
    • Contraindication to oral anticoagulation
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    =============
    • Change in quality of life, defined as change in the SF-36 Physical Component Summary Scale Score after 3 months of treatment
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned21
    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 Information not present in EudraCT
    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
    The treatment period per patient is 6 to 7 months. The end of the study is defined as the last patient last visit date.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 state270
    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 Decision2010-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
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