Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004399-68
    Sponsor's Protocol Code Number:1925-201-008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-004399-68
    A.3Full title of the trial
    A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery
    Estudio de fase 2, multicéntrico, aleatorizado, con enmascaramiento doble y controlado con placebo de búsqueda de dosis para evaluar la eficacia y la seguridad de inyecciones de toxina botulínica de tipo A (AGN-151607) en las almohadillas grasas epicárdicas para prevenir la fibrilación auricular posoperatoria en pacientes sometidos a cirugía cardíaca de tórax abierto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial fibrillation in patients undergoing open-chest cardiac surgery
    Toxina botulínica de tipo A (AGN-151607) para prevenir la fibrilación auricular posoperatoria en pacientes sometidos a cirugía cardíaca de tórax abierto
    A.4.1Sponsor's protocol code number1925-201-008
    A.5.4Other Identifiers
    Name:IND numberNumber:135000
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailML-CTRG@Allergan.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 nameClostridium botulinum neurotoxin type A (BoNT/A) complex
    D.3.2Product code AGN-151607
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 1883793-14-3
    D.3.9.2Current sponsor codeAGN-151607
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM
    D.3.9.4EV Substance CodeSUB130769
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 nameClostridium botulinum neurotoxin type A (BoNT/A) complex
    D.3.2Product code AGN-151607
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 1883793-14-3
    D.3.9.2Current sponsor codeAGN-151607
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM
    D.3.9.4EV Substance CodeSUB130769
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative atrial fibrillation (POAF)
    Fibrilación auricular posoperatoria (FAPO)
    E.1.1.1Medical condition in easily understood language
    Prevention of post-operative atrial fibrillation
    Prevención de fibrilación auricular posoperatoria
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of AGN-151607 with placebo to prevent post-operative atrial fibrillation (POAF) in participants who are undergoing open chest cardiac surgery
    Comparar la eficacia de AGN-151607 con la de un placebo para prevenir la fibrilación auricular posoperatoria (FAPO) en participantes sometidos a cirugía cardíaca de tórax abierto
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of AGN-151607 with placebo to reduce AF burden in participants who are undergoing open-chest cardiac surgery
    - To compare the efficacy of AGN-151607 with placebo to prevent POAF using alternative definitions for AF in participants who are undergoing open-chest cardiac surgery
    - To compare the safety of AGN-151607 with placebo in participants undergoing open-chest cardiac surgery
    - Comparar la eficacia de AGN-151607 con la de un placebo para reducir la carga de FA en participantes sometidos a cirugía cardíaca de tórax abierto
    - Comparar la eficacia de AGN-151607 con la de un placebo para prevenir la FAPO utilizando definiciones alternativas para la FA en participantes sometidos a cirugía cardíaca de tórax abierto
    - Comparar la seguridad de AGN-151607 con la de un placebo en participantes sometidos a cirugía cardíaca de tórax abierto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 55 to 90 years of age, inclusive, at the time of signing the informed consent;
    - scheduled to undergo open-chest cardiac surgery (includes: coronary artery bypass graft [CABG] and/or valve repair/replacement);
    - in sinus rhythm for the last 48 hours prior to surgery (prior history of paroxysmal AF is acceptable);
    - willing to wear an electrocardiogram (ECG) patch for 30 days post-surgery and for 7 days after each study visit.
    - tener 55 a 90 años de edad, inclusive, en el momento de firmar el consentimiento informado;
    - tener programada una intervención de cirugía cardíaca de tórax abierto (incluye: derivación coronaria y/o valvuloplastia/sustitución valvular);
    - haber estado en ritmo sinusal durante las 48 horas previas a la intervención quirúrgica (se aceptan los antecedentes de FA paroxística);
    - estar dispuesto a utilizar un parche de electrocardiograma (ECG) durante 30 días después de la intervención quirúrgica y durante 7 días después de cada visita del estudio.
    E.4Principal exclusion criteria
    - any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne’s muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function;
    - participants with presence or history of any of the following within 3 months prior to the Day 1 visit that may indicate a vulnerable respiratory state per the investigator’s clinical judgment: aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease or otherwise compromised respiratory function;
    - permanent/persistent AF;
    - has a known allergy or sensitivity to any botulinum toxin type A preparation;
    - has a known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive; hydrogel based adhesive); severe (> 55mm) atrial enlargement; left ventricular ejection fraction (LVEF) < 25%;
    - presence or history of symptomatic atrioventricular block > 1st degree within the last 30 days;
    - prior or concomitant therapy with Class I or III antiarrhythmic drugs unless proper washout was documented;
    - botulinum toxin type A (of any serotype) use within 6 months of randomization;
    - has been immunized for any botulinum toxin type A serotype as determined by participant medical history;
    - preoperative need for inotropes/vasopressors or intra-aortic balloon pump;
    - prior cardiac surgery;
    - history of ablation for AF;
    - planned ablation procedure for AF at the time of surgery;
    - emergency surgery;
    - impaired prognosis defined as EuroSCORE II greater than 7% perioperative mortality.
    - cualquier trastorno médico que pueda suponer un mayor riesgo para el participante con la exposición a la toxina botulínica de tipo A, tal como distrofia muscular diagnosticada (p. ej., distrofia muscular de Duchenne), miastenia grave, síndrome de Eaton-Lambert, esclerosis lateral amiotrófica, enfermedad mitocondrial o cualquier otra enfermedad importante que pueda interferir en la función neuromuscular;
    - los participantes con presencia o con antecedentes de cualquiera de los siguientes trastornos en los 3 meses previos a la visita del día 1, que podrían indicar un estado respiratorio vulnerable conforme al criterio clínico del investigador: neumonía aspirativa, infecciones respiratorias bajas, asma no controlada, enfermedad pulmonar obstructiva crónica grave u otra alteración de la función respiratoria;
    - FA permanente/persistente;
    - alergia o sensibilidad conocidas a la preparación de toxina botulínica de tipo A;
    - alergia o sensibilidad conocidas a los adhesivos médicos (p. ej., el adhesivo de los parches de ECG, adhesivos a base de hidrogel);
    dilatación auricular grave (> 55 mm);
    - fracción de eyección del ventrículo izquierdo (FEVI) < 25 %;
    - presencia o antecedentes de bloqueo auriculoventricular sintomático de segundo grado o mayor en los últimos 30 días;
    - tratamiento previo o concomitante con antiarrítmicos de clase I o III a menos que se haya documentado un período de lavado adecuado;
    - uso de toxina botulínica de tipo A (de cualquier serotipo) en los 6 meses previos a la aleatorización;
    - haber recibido inmunización para cualquier serotipo de la toxina botulínica de tipo A conforme a la anamnesis del participante;
    - necesidad preoperatoria de fármacos inotrópicos/vasopresores o de una bomba con balón intraaórtico;
    - cirugía cardíaca previa; antecedentes de ablación por FA;
    - ablación programada por FA en el momento de la cirugía;
    - cirugía de urgencia;
    - mal pronóstico definido como una puntuación EuroSCORE II > 7 % de mortalidad perioperatoria.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode ≥ 30 seconds during the first 30 days post surgery
    Porcentaje de participantes con al menos 1 episodio de fibrilación auricular (FA) continua ≥ 30 segundos durante los 30 primeros días después de la cirugía
    E.5.1.1Timepoint(s) of evaluation of this end point
    within the first 30 days post surgery
    durante los 30 primeros días después de la cirugía
    E.5.2Secondary end point(s)
    - Percentage of time spent in AF (AF burden) during the first 30 days post surgery
    - Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post surgery
    - Time to first occurrence of AF during the first 30 days post surgery
    - Percentage of participants with at least 1 continuous AF episode ≥ 2 minutes during the first 30 days post-surgery
    - Percentage of participants with at least 1 continuous AF episode ≥ 5 minutes during the first 30 days post-surgery
    - Percentage of participants with at least 1 continuous AF episode ≥ 30 minutes during the first 30 days post-surgery
    - Percentage of participants with at least 1 continuous AF episode ≥ 1 hour during the first 30 days post surgery
    - Percentage of participants with at least 1 continuous AF episode ≥ 4 hours during the first 30 days post surgery
    - Percentage of participants with at least 1 continuous AF episode ≥ 24 hours during the first 30 days post surgery
    - Adverse events (AEs), physical examination, clinical laboratory tests, vital signs, electrocardiogram (ECGs), pulmonary function
    - Potential immunogenicity response
    - Porcentaje del tiempo transcurrido en FA (carga de FA) durante los 30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA sintomática durante los 30 primeros días después de la cirugía
    - Tiempo transcurrido hasta la primera aparición de FA durante los 30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA continua ≥ 2 minutos durante los 30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA continua ≥ 5 minutos durante los 30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA continua ≥ 30 minutos durante los
    30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA continua ≥ 1 hora durante los 30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA continua ≥ 4 horas durante los 30 primeros días después de la cirugía
    - Porcentaje de participantes con al menos 1 episodio de FA continua ≥ 24 horas durante los 30 primeros días después de la cirugía
    E.5.2.1Timepoint(s) of evaluation of this end point
    within the first 30 days post surgery
    durante los 30 primeros días después de la cirugía
    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 trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Canada
    Germany
    Italy
    Netherlands
    Russian Federation
    Spain
    Sweden
    United Kingdom
    United States
    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
    Última Visita Ultimo Sujeto
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 330
    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
    Ninguno
    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 Decision2018-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Oct 31 12:44:24 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA