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    Summary
    EudraCT Number:2012-003487-48
    Sponsor's Protocol Code Number:F373280CA201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-28
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-003487-48
    A.3Full title of the trial
    Efficacy and safety international, multicentric, randomised,double- blind,placebo controlled study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.
    Az F373280 hatékonyságának és biztonságosságának multicentrikus, randomizált, kettős-vak,placebo kontrollált vizsgálata szinusz ritmus fenntartásában elektromos kardioverziót követően, tartós pitvarfibrillációban és krónikus szívelégtelenségben szenvedő betegek esetében.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of F373280
    Az F373280 hatékonyságának és biztonságosságának vizsgálata
    A.4.1Sponsor's protocol code numberF373280CA201
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT DE RECHERCHE PIERRE FABRE - Centre de R&D Pierre Fabre
    B.5.2Functional name of contact pointALCARAZ Gaelle
    B.5.3 Address:
    B.5.3.1Street AddressINSTITUT DE RECHERCHE PIERRE FABRE - Centre de R&D Pierre Fabre - BP 13562 - 3 avenue Hubert Curien
    B.5.3.2Town/ cityTOULOUSE Cédex 1
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number0033(0)5 34 50 62 16
    B.5.5Fax number0033(0)5 34 50 69 69
    B.5.6E-mailgaelle.alcaraz@pierre-fabre.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 namepanthenyl ester of DHA
    D.3.2Product code F373280
    D.3.4Pharmaceutical form Capsule, soft
    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 INNpanthenyl ester of DHA
    D.3.9.2Current sponsor codeF373280
    D.3.9.3Other descriptive nameDOCOSAHEXAENOIC ACID PANTHENYL ESTER
    D.3.9.4EV Substance CodeSUB33358
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    F373280 is a new therapy based on DHA delivery (pro-drug) developed for the maintenance of sinus rhythm after electrical cardioversion in persistent atrial fibrillation (AF) patients with chronic heart failure.
    The results of a pharmacological study performed in animals evidenced that DHA reduces the duration of Atrial Fibrillation (AF) induced by burst pacing.
    E.1.1.1Medical condition in easily understood language
    F373280 is a new therapy based on DHA delivery developed for the maintenance of sinus rhythm after electrical cardioversion in persistent atrial fibrillation patients with chronic heart failure.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term 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
    Primary:
    Efficacy of F373280 on the maintenance of sinus rhythm after direct electrical cardioversion in patients with persistent atrial fibrillation and chronic heart failure
    E.2.2Secondary objectives of the trial
    Secondary:
    - Efficacy of F373280 on the efficiency of direct electrical cardioversion
    - Effect of F373280 on echocardiographic parameters
    - Safety and tolerability of F373280
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic Characteristics and Other Baseline Characteristics:
    1.Men or women aged more than 18 years (inclusive)
    2.Patients with current episode of persistent AF between 7 days and 6
    months duration for whom electrical cardioversion is warranted
    3.Previous history of first documented episode of persistent AF.
    4.Previous history of ischemic or non ischemic heart failure
    5.NYHA class I or II chronic heart failure at selection and at inclusion
    6.Left ventricular systolic dysfunction defined at selection and at
    inclusion by a reduced left ventricular ejection fraction (LVEF) ≥ 30%
    and ≤ 45% or for patients with a LVEF > 45%:
    •an increased left ventricular end-diastolic size (diameter ≥ 60 mm
    and/or > 32 mm/m² and/or volume > 97 ml/m²)
    •and/or an increased left ventricular end-systolic size
    (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²)
    •and/or a reduced left ventricular outflow tract velocity time integral <
    15 cm
    7.On appropriate, stable medical treatments for heart failure, including a
    diuretic and/or angiotensin-converting enzyme, and/or angiotensin-
    receptor blocker and/or mineralocorticoid receptor (MR) antagonists,
    and/or betablockers
    8.Left atrial area ≤ 40 cm² at selection and at inclusion
    9.Patients treated or having to be treated by vitamin K antagonist
    10.For female patient of child-bearing potential:
    •In all the countries except Italy:
    -Use of an effective method of contraception (hormonal contraception or
    intra-uterine device) assessed by the investigator, for at least 2 months
    before the selection in the study, and agreement to go on using it during
    the whole duration of the study and up to 1 month after the last dose of
    the study treatment
    -Documented as surgically sterilized
    •In Italy only:
    -Absolute abstention from sexual intercourse during the whole duration
    of the study and for a month after the end of the study or
    -Use of double barrier contraception method (use of effective medical
    contraception method) from at least 2 months before the start of the
    study to the entire duration of the study and for a month after the end of
    the study or
    -Documented as surgically sterilized
    11.For female patient of child-bearing potential: negative urine
    pregnancy test at inclusion
    12.For male with a child-bearing potential partner (In Italy only):
    -Absolute abstention from sexual intercourse during the whole duration
    of the study and for 3 months after the end of the study or
    -Use of double barrier contraception method (use of condom for male
    and effective contraception method for the partner) from the entire
    duration of the study to 3 months after the end of the study.
    Ethical / legal considerations:
    13.Having signed his/her written informed consent,
    14.Affiliated to a social security system, or is beneficiary (if applicable in
    the national regulation)
    E.4Principal exclusion criteria
    Non-Inclusion Criteria:
    Criteria related to pathologies:
    1.No previous history of first documented episode of persistent AF
    2.More than two successful cardioversions (electrical or
    pharmacological) in the last 6 months
    3.Secondary Atrial Fibrillation due to alcohol or severe valvular heart
    disease (grade III to IV)
    4.NYHA class III or IV heart failure at selection or at inclusion
    5.Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be
    checked in case of treatment for thyroid disease
    6.Myocardial infarction or unstable angina or presence of unstable
    ischemic coronaropathy assessed by coronarography or cardiac stress
    test (Echo stress, exercise stress test, nuclear or MR perfusion
    evaluation methods) within 6 months before selection
    7.Severe chronic kidney disease (creatinine ≥ 25 mg/L or estimated
    glomerular filtration rate < 30 ml/min) at selection
    8.Bradycardia (HR ≤ 50 bpm)
    9.Hyperkalemia or hypokalemia (according to the standards of local
    laboratories) at selection
    10.Cardiac surgery within 3 months before selection or planned during
    the study duration
    Criteria related to treatments:
    11.Previously ineffective pharmacological or electrical cardioversion
    12.Concomitant treatment with ranolazine or any antiarrhythmic drug
    (within 7 days prior to selection), except amiodarone, dronedarone and
    stable dose of digoxin, betablockers, calcium-blockers
    13.Concomitant treatment with oral amiodarone or dronedarone from
    selection
    14.Concomitant treatment with intravenous amiodarone from selection
    15.Patient requiring a cardiac resynchronization therapy (CRT) or having
    undergone CRT implantation within the last 6 months
    16.Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last
    3 months
    17.Dietary supplement with ω 3 or ω 6 according to investigator's
    judgement
    18.Having undergone any form of ablation therapy for AF
    19.Patient treated with oral anticoagulant treatment other than vitamin
    K antagonist: new oral anticoagulants (dabigatran, rivaroxaban,
    apixaban), or treated with irreversible antiplatelet agents P2Y12
    inhibitors such as ticlopidine, clopidogrel or prasugrel
    Other criteria:
    20.Patient liable not to comply with protocol instructions and/or with
    treatment, in the investigator's opinion
    21.Patient having taken part in a clinical trial in the preceding 2 months
    or taking part in a trial at the time of selection
    22.Patient linguistically or mentally unable to understand the nature,
    objectives and possible consequences of the trial, or refusing to patient
    himself/herself to its constraints
    23.Patient family member or work associate (secretary, nurse,
    technician,..) of the Investigator
    24.Patient having forfeited his / her freedom by administrative or legal
    award or being under guardianship
    25. Breastfeeding female patient
    E.5 End points
    E.5.1Primary end point(s)
    efficacy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first Atrial Fibrillation recurrence or atrial flutter emergence
    defined by the time to first episode of AF or atrial flutter lasting for at
    least 10 minutes.
    E.5.2Secondary end point(s)
    safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events
    Vital signs
    Physical examination
    Standard 12-lead ECG
    Haematology
    Biochemistry
    Coagulation parameters
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months3
    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.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 152
    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 Decision2013-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-03
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