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    Summary
    EudraCT Number:2015-001464-19
    Sponsor's Protocol Code Number:GE-122-020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-12-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-001464-19
    A.3Full title of the trial
    AdreView Myocardial Imaging for Risk Evaluation. A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 30%</=LVEF</=35%. ADMIRE-ICD
    Obtención de imágenes del miocardio con AdreView para la evaluación de los riesgos. Ensayo multicéntrico para guiar la implantación de DCI en pacientes con insuficiencia cardíaca de clases NYHA II y III con 30% </=FEVI</=35%. ADMIRE-ICD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre trial to find out whether imaging can be used to see whether heart failure patients will benefit from a device to regulate their heart
    Ensayo multicéntrico para averiguar si la imagen se puede utilizar para ver si los pacientes con insuficiencia cardíaca se beneficiarán de un dispositivo para regular su corazón
    A.4.1Sponsor's protocol code numberGE-122-020
    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 SponsorGE Healthcare Ltd. and its affiliates
    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 supportGE Healthcare Ltd. and its affiliates
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd.
    B.5.2Functional name of contact pointMedical Director - Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressThe Grove Centre, White Lion Road
    B.5.3.2Town/ cityAmersham, Buckinghamshire
    B.5.3.3Post codeHP7 9LL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailinfo@ge.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 Yes
    D.2.1.1.1Trade name AdreView
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare B.V.
    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 nameAdreView
    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.3.8INN - Proposed INN[123I]iobenguane
    D.3.9.3Other descriptive nameIOBENGUANE 123I INJECTION FOR DIAGNOSTIC USE
    D.3.9.4EV Substance CodeSUB127285
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/ml millicurie(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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
    Heart failure
    Insuficiencia cardíaca
    E.1.1.1Medical condition in easily understood language
    Heart failure
    Insuficiencia cardíaca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10064081
    E.1.2Term Heart failure NYHA class III
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10064080
    E.1.2Term Heart failure NYHA class II
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of ICD implantation in a population of New York Heart Association (NYHA) class II and III Heart Failure (HF) patients with 30%≤LVEF≤35%. This will be achieved by comparing allcause mortality observed in the AdreView™guided therapy group to that observed in patients receiving the Standard of Care (SoC; defined as the medical care as recommended by internationally accepted HF guidelines), in whom no clinical decision will be made based upon AdreView™ scan results.
    Demostrar la eficacia de las imágenes obtenidas con AdreView™ para guiar adecuadamente la decisión sobre la implantación de un DCI en una población de pacientes con insuficiencia cardíaca (IC) de clases II y III según la clasificación de la Asociación de Cardiología de Nueva York (New York Heart Association, NYHA), con 30% ≤ fracción de eyección ventricular izquierda (FEVI) ≤ 35%. Esto se logrará mediante la comparación de la mortalidad por cualquier causa observada en el grupo de tratamiento guiado por AdreView™ con la observada en los pacientes que reciban atención según las normas asistenciales (NA, definidas como la atención médica recomendada según las directrices internacionalmente aceptadas sobre la IC), sobre los cuales no se tomará ninguna decisión clínica como consecuencia de los resultados de la exploración con AdreView™
    E.2.2Secondary objectives of the trial
    Compare the rate of hospitalisation and death related to major complications of ICD implantation and a composite of the rate of complications of long-term device therapy in patients randomised to the AdreView group with a heart-to-mediastinal ratio (H/M)) ≥1.6 with patients in the SoC group with H/M ) ≥1.6
    Compare AdreView-guided therapy to SoC therapy for:
    -occurrence of cardiac death
    -rate of hospitalisation for cardiovascular cause
    -rate of all-cause hospitalisation
    -composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest
    -occurrence of syncope
    -clinical and healthcare resource utilisation data including ICD implantation, all hospitalisations, treatment of adverse events and AdreView administration
    Composite of the rate of hospitalisation and death related to major complications of device implantation and composite of the rate of complications of long-term device therapy
    Comparar tasa de hospitalización (hosp) y muerte relacionada con complicaciones graves de la implantación (impl) del DCI y combinación tasa de complicaciones del tto a largo plazo con el dispositivo (disp) en pacientes asignados aleatoriamente al grupo de AdreView con un índice C/M≥1,6 con respecto a los pacientes del grupo de NA con un C/M≥1,6.
    Comparar el tto guiado por AdreView con las NA en cuanto a:Incidencia de muertes de origen cardíaco.Tasa de hosp por causas cardiovasculares y por cualquier causa.Combinación incidencia de taquicardia ventricular potencialmente mortal con reanimación,taquiarritmia ventricular inestable,MSC y paro cardíaco con reanimación.Incidencia de síncopes.Los datos sobre la utilización de recursos clínicos y sanitarios,incluidos la impl. de DCI,todas las hosp,el tto de los AAs y la administración de AdreView.
    Combinación tasa: de hosp y muerte relacionada con complicaciones graves de la impl. del disp y de complicaciones del tto a largo plazo con el disp
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Patients ≥ 18 years of age at the time dated informed consent is obtained.
    (2) Female patients must be pre-menarchal, surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or, if of childbearing potential, a serum or urine pregnancy test with the results known prior to AdreView™ (Iobenguane I123 Injection) administration) is negative.
    (3) Patients willing and able to comply with all study procedures and a signed and dated informed consent is obtained before any study-procedure is carried out.
    (4) Heart failure NYHA classes II or III for symptoms, patients with ischemic or non-ischemic heart disease, eligible for ICD implantation as per each site’s standard of practice.
    (5) Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration.
    (6) 30%≤LVEF≤35%, performed at time of enrolment, as measured by radionuclide ventriculography, or electrocardiogram [ECG]-gated SPECT myocardial perfusion imaging [MPI], or magnetic resonance imaging [MR], computed tomography [CT], or 3D or 2D echocardiography [Simpson’s or multidisc method or equivalent only, M-mode echocardiography is not accepted].
    (7) Clinically stable HF in the medical judgment of the investigator (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor’s office) for the past 30 days and no hospitalisation for HF or acute coronary syndrome (including myocardial infarction) in the past 40 days.
    (8) Reasonable expectation of meaningful survival for at least 1 year.
    (1) Pacientes con ≥ 18 años de edad en la fecha en que se obtenga el consentimiento informado.
    (2) Las pacientes de sexo femenino deben ser premenárquicas, quirúrgicamente estériles (con ovariectomía bilateral documentada o histerectomía documentada), posmenopáusicas (ausencia de menstruación durante más de 1 año), y no estar en periodo de lactancia. Si poseen capacidad reproductiva, deben tener una prueba de embarazo en suero u orina con resultado negativo, que debe conocerse antes de la administración de AdreView™ (inyección de iobenguano 123I).
    (3) Los pacientes deben estar dispuestos y ser capaces de cumplir con todos los procedimientos del estudio, y se obtendrá un consentimiento informado firmado y fechado antes de que se realice cualquiera de los procedimientos del estudio.
    (4) Insuficiencia cardíaca de clases NYHA II o III en cuanto a los síntomas, pacientes con cardiopatía isquémica o no isquémica aptos para la implantación de un DCI de acuerdo con la práctica habitual de cada centro.
    (5 ) Miocardiopatía dilatada no isquémica o cardiopatía isquémica de al menos 3 meses de duración.
    (6) 30%≤FEVI≤35 %, obtenida en el momento de la inclusión, medida por ventriculografía con radionúclidos, imágenes de perfusión miocárdica (IPM) de SPECT sincronizadas con el electrocardiograma (ECG), resonancia magnética (RM), tomografía axial computarizada (TAC) o ecocardiografía 3D o 2D (únicamente con el método de Simpson o de discos múltiples o equivalente, no se acepta la ecocardiografía en modo M).
    (7) IC clínicamente estable según el criterio médico del investigador (es decir, sin cambios significativos en la medicación, sin empeoramiento de los síntomas, sin visitas no programadas al consultorio del médico) durante los últimos 30 días y sin hospitalización por la IC o por síndrome coronario agudo (incluido el infarto de miocardio) en los 40 días anteriores.
    (8) Expectativa razonable de supervivencia significativa durante al menos 1 año.
    E.4Principal exclusion criteria
    (1) Patients with existing ICD or patient having an indication of ICD implantation for secondary prevention of SCD.
    (2) Hospitalisation for HF or for acute coronary syndrome in the previous 40 days.
    (3) Patients where a cardiac resynchronisation therapy (CRT) is planned or indicated
    (4) Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing).
    (5) NYHA class I or class IV symptoms at the time of study entry.
    (6) American College of Cardiology-American Heart Association (ACC-AHA) class III or class IV (unstable) angina.
    (7) Patient with chronic renal insufficiency defined as serum creatinine ≥3 mg/dl (or 265.2 µmol/L).
    (8) Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView™ (Iobenguane I123 Injection).
    (9) Patient who is pregnant or plans to become pregnant within 2 weeks after AdreView™ (Iobenguane I123 Injection) administration.
    (10) Patient who has used any medication in the 2 weeks before AdreView™(Iobenguane I123 Injection) that could interfere with the test: e.g., but not limited to amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs known or suspected to inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine.
    (11) Patients that have a medical condition that could interfere with the AdreView™ test (e.g., but not limited to left ventricular assist device, or prior heart transplant).
    (12) Patients who participated in a clinical study involving a drug or device within 30 days prior to study entry and patients participating in any other clinical study.
    (13) Patients having serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma.
    (14) Patients with a clinical diagnosis of (or being treated for) Parkinson ´s disease or Multiple System Atrophy.
    (15) The patient has participated in a research study using ionizing radiation in the previous 12 months.
    (16) Patients previously enrolled in this study.
    (1) Pacientes que tengan ya un DCI o en los que esté indicada la implantación de un DCI para la prevención secundaria de la MSC.
    (2) Hospitalización por IC o por síndrome coronario agudo en los 40 días previos.
    (3) Pacientes en los que esté previsto o indicado un tratamiento de resincronización cardíaca (TRC).
    (4) Otra indicación para la colocación de un dispositivo (taquicardia ventricular sostenida, muerte súbita con reanimación, necesidad de estimulación auriculoventricular con marcapasos).
    (5) Síntomas de las clases NYHA I o IV en el momento de la inclusión en el estudio.
    (6) Angina de clases III o IV (inestable) según la clasificación del American College of Cardiology-American Heart Association (Colegio Estadounidense de Cardiología y Asociación Estadounidense del Corazón, ACC-AHA).
    (7) Pacientes con insuficiencia renal crónica, definida como creatinina sérica ≥3 mg/dl (o 265,2 µmol/l).
    (8) Hipersensibilidad o alergia conocida, o sospecha de hipersensibilidad o alergia al iobenguano o a cualquiera de los excipientes de AdreView™ (inyección de Iobenguano 123I).
    (9) Pacientes embarazadas o con intención de quedar embarazada en las 2 semanas posteriores a la administración de AdreView™ (inyección de iobenguano 123I).
    (10)Pacientes que hayan tomado cualquier medicamento durante las 2 semanas previas a la administración de AdreView™ (inyección de iobenguano 123I) que pueda interferir en la prueba: p. ej., entre otros, amitriptilina o sus derivados, imipramina o sus derivados, otros antidepresivos o fármacos que tengan un efecto conocido o sospechado de inhibición del transportador de noradrenalina, antihipertensivos que reduzcan los niveles de noradrenalina o que inhiban su recaptación, aminas simpaticomiméticas o cocaína.
    (11) Pacientes que tengan una afección médica que pueda interferir en la prueba AdreView™ (p. ej., entre otros, un dispositivo de asistencia en el ventrículo izquierdo o un trasplante cardíaco previo).
    (12) Pacientes que hayan participado en un estudio clínico con un fármaco o dispositivo en los 30 días previos a su entrada en el estudio o pacientes que estén participando en cualquier otro estudio clínico.
    (13) Pacientes que tengan una afección médica no cardíaca grave asociada a una elevación significativa de las catecolaminas plasmáticas, incluido un feocromocitoma.
    (14) Pacientes con diagnóstico clínico de (o que estén siendo tratados por) enfermedad de Parkinson o atrofia multisistémica.
    (15) Pacientes que hayan participado en un estudio de investigación en el que se utilizase radiación ionizante en los 12 meses previos.
    (16) Pacientes que hayan sido incluidos previamente en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be all-cause mortality
    El criterio de valoración principal será la mortalidad por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of this study will be dependent on the time taken to achieve a total of 247 primary endpoint events in the randomised part of the study. The expected mean observational time per patient is 2.75 to 3 years
    La duración total prevista del estudio es de aproximadamente 4 años, y el número total obligatorio de eventos del criterio de valoración principal observados es de 247.
    Está previsto que los pacientes participen en el estudio hasta que se hayan acumulado suficientes criterios de valoración, lo que puede corresponder a un seguimiento individual medio de 2,75 a 3 años.
    E.5.2Secondary end point(s)
    - A composite of the rate of hospitalisation and death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery) and a composite of the rate of complications of long-term device therapy (i.e., infection not leading to hospitalisation, lead and/or generator removal/replacement, inappropriate shocks, explantation). (AdreView™ Low-risk group vs SoC H/M ≥1.6)
    - Cardiac death (composed of SCD, death due to cardiac arrhythmia, death due to HF, and death due to other cardiovascular causes)
    - The rate of hospitalisation for cardiovascular cause.
    - The rate of all-cause hospitalisation.
    - A composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest.
    - Una combinación de la tasa de hospitalización y muerte relacionada con complicaciones graves de la implantación del dispositivo (es decir, necesidad de toracotomía, pericardiocentesis o intervención quirúrgica vascular) y una combinación de la tasa de complicaciones del tratamiento a largo plazo con el dispositivo (es decir, infección que no desemboque en hospitalización, retirada/sustitución de derivaciones/del generador, choques inadecuados, explantación). (Grupo de bajo riesgo de AdreView™ frente a NA con C/M ≥ 1,6).
    - Muerte de origen cardíaco (que comprende MSC, muerte por arritmia cardíaca, muerte por IC y muerte por otras causas cardiovasculares).
    - La tasa de hospitalización por causas cardiovasculares.
    - La tasa de hospitalización por cualquier causa.
    - Una combinación de la incidencia de taquicardia ventricular potencialmente mortal con reanimación, taquiarritmia ventricular inestable, MSC y paro cardíaco con reanimación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The duration of this study will be dependent on the time taken to achieve a total of 247 primary endpoint events in the randomised part of the study. The expected mean observational time per patient is 2.75 to 3 years
    La duración total prevista del estudio es de aproximadamente 4 años, y el número total obligatorio de eventos del criterio de valoración principal observados es de 247.
    Está previsto que los pacientes participen en el estudio hasta que se hayan acumulado suficientes criterios de valoración, lo que puede corresponder a un seguimiento individual medio de 2,75 a 3 años.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Event-driven
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care cohort
    E.8.2.4Number of treatment arms in the trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    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
    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 months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    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.1.2.1Number of subjects for this age range: 1351
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 865
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-12-28. Yes
    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 state168
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1816
    F.4.2.2In the whole clinical trial 2216
    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)
    Standard care
    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 Decision2016-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    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.

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