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    Summary
    EudraCT Number:2012-001898-90
    Sponsor's Protocol Code Number:Crijns01.12-02-026
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001898-90
    A.3Full title of the trial
    Effects of vernakalant and flecainide on atrial contractility in patients with atrial fibrillation
    De effecten van vernakalant en flecaïnide op de atriale contractiliteit bij patiënten met atriumfibrilleren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of vernakalant and flecainide on atrial contractility in patients with AF
    De effecten van vernakalant en flecaïnide op de knijpkracht van de boezems bij patiënten met boezemfibrilleren
    A.3.2Name or abbreviated title of the trial where available
    Vernakalant versus flecainide: atrial contractility
    Vernakalant versus flecaïnide: atriale contractiliteit
    A.4.1Sponsor's protocol code numberCrijns01.12-02-026
    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 SponsorMaastricht University Medical Center
    B.1.3.4CountryNetherlands
    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 supportMaastricht University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointSecretary Cardiology
    B.5.3 Address:
    B.5.3.1Street AddressP.Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 HX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31433875093
    B.5.5Fax number+31433875104
    B.5.6E-mailhjgm.crijns@mumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Brinavess
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    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 nameBrinavess
    D.3.2Product code SUB30707
    D.3.4Pharmaceutical form Concentrate for solution 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.3.9.1CAS number 748810-28-8
    D.3.9.3Other descriptive nameVERNAKALANT HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB30707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number339
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Tambocor
    D.2.1.1.2Name of the Marketing Authorisation holderMeda Health Sales
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameTambocor
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 54143-56-5
    D.3.9.3Other descriptive nameFLECAINIDE ACETATE
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number150
    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
    Patients with paroxysmal or persistent atrial fibrillation (AF) reporting at the first heart aid.
    Patiënten met paroxysmaal of persisterend atriumfibrilleren (AF) die zich melden op de eerste hart hulp.
    E.1.1.1Medical condition in easily understood language
    Patients with atrial fibrillation (heart rhythm disorder) reporting at the first heart aid.
    Patiënten met boezemfibrilleren (hartritmestoornis) die zich melden op de eerste hart hulp.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the atrial contractility by means of echocardiography between patients receiving flecainide and vernakalant i.v. after conversion to sinus rhythm.
    Om de atriale contractiliteit na conversie naar sinusritme middels echocardiografie te vergelijken tussen patiënten die flecaïnide en vernakalant i.v. krijgen.
    E.2.2Secondary objectives of the trial
    a. To compare the conversion rate of AF between patients receiving flecainide and vernakalant i.v.
    b. To compare the recurrence rate of AF four weeks after successful cardioversion between patients receiving flecainide and vernakalant i.v.
    a. Om het conversiepercentage van atriumfibrilleren te vergelijken bij patiënten die flecaïnide en vernakalant i.v. krijgen.
    b. Om het aantal recidieven van AF te vergelijken vier weken na succesvolle cardioversie bij patiënten die flecaïnide en vernakalant i.v. krijgen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients presenting with paroxysmal or persistent AF
    - eligible for treatment with flecainide or vernakalant infusion to restore sinus rhythm
    - receiving adequate anticoagulant therapy (or having an episode of AF lasting < 24 hours)
    - patiënten die zich presenteren met paroxysmaal of persisterend AF
    - geschikt voor behandeling met flecïnide of vernakalant infuus om het ritme te herstellen naar sinusritme
    - patiënten moeten adequate antistollingstherapie hebben (of de episode van AF moet minder dan 24 uur duren op het moment van presentatie)
    E.4Principal exclusion criteria
    - atrial flutter
    - contra-indications for receiving flecainide or vernakalant infusion according to MUMC+ protocol (unstable hemodynamic condition, LVEF < 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction)
    - age < 18 years
    - atriumflutter
    - contra-indicaties voor flecaïnide en vernakalant volgens protocol MUMC+ (hemodynamisch instabiele toestand, LVEF < 40%, inadequate kaliumconcentraties, sinusknoopdysfunctie)
    - leeftijd < 18 jaar
    E.5 End points
    E.5.1Primary end point(s)
    Echocardiography to evaluate atrial contractility after conversion to sinus rhythm.
    Echocardiografie om de atriale contractiliteit te evalueren na conversie naar sinusritme.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Directly after successfull cardioversion.
    Direct na succesvolle cardioversie.
    E.5.2Secondary end point(s)
    a. Conversion rate to sinus rhythm.
    b. Recurrence of AF at one month follow-up.
    a. Aantal conversie's naar sinusritme.
    b. Recidief van AF bij 1 maand follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. One hour after start infusion vernakalant or flecainide.
    b. One month after first heart aid visit (follow-up).
    a. Eén uur na start van infuus vernakalant of flecaïnide.
    b. Eén maand na het eerste hart-hulp bezoek (follow-up).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The patient has completed the study when he/she has received the echocardiography and electrocardiogram at the one-month follow-up after the first-heart aid visit.
    De patiënt is klaar met de studie wanneer hij/zij de echocardiografie en het electrocardiogram heeft gehad bij de 1-maand follow-up na het eerste hart hulp bezoek.
    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 months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    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.
    Geen.
    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 Decision2012-05-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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