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    Summary
    EudraCT Number:2016-003653-15
    Sponsor's Protocol Code Number:AC-055G202
    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:2017-04-20
    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 number2016-003653-15
    A.3Full title of the trial
    A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease
    Estudio de fase IIb, multicéntrico, con doble enmascaramiento y controlado con placebo para evaluar la eficacia y la seguridad de macitentan en pacientes con insuficiencia cardíaca con fracción de eyección preservada y vasculopatía pulmonar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular disease
    Un estudio para evaluar si macitantan es un tratamiento eficaz y seguro para pacientes con insuficiencia cardíaca con fracción de eyección preservada y enfermedad vascular pulmonar
    A.3.2Name or abbreviated title of the trial where available
    SERENADE
    A.4.1Sponsor's protocol code numberAC-055G202
    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 SponsorACTELION Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 supportACTELION Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationACTELION Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical trial disclosure desk
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinical-trials-disclosure@actelion.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 Opsumit
    D.2.1.1.2Name of the Marketing Authorisation holderActelion Registration Ltd
    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 namemacitentan
    D.3.2Product code ACT-064992
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNMACITENTAN
    D.3.9.1CAS number 441798-33-0
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    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
    Heart failure with preserved ejection fraction and pulmonary vascular disease
    Insuficiencia cardíaca con fracción de eyección preservada y vasculopatía pulmonar
    E.1.1.1Medical condition in easily understood language
    Left heart failure (inability of the heart to pump enough blood) may lead to increased pressure in the lung blood vessels. This increases the right heart workload and may lead to right heart failure.
    Insuficiencia cardíaca izquierda puede conducir a mayor presión en los vasos sanguíneos del pulmón. Esto aumenta carga de trabajo del corazón derecho y puede conducir a insuficiencia cardíaca derecha.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10076396
    E.1.2Term Heart failure with preserved ejection fraction
    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
    The primary objective of the study is to evaluate whether macitentan 10 mg reduces NT-pro-BNP versus placebo at Week 24 in subjects with HFpEF and pulmonary vascular disease
    Evaluar si 10 mg de macitentan reducen la prohormona N-terminal del péptido natriurético cerebral (NT-proBNP) en comparación con el placebo en la semana 24 en pacientes con insuficiencia cardíaca con fracción de eyección preservada (ICFEP) y vasculopatía pulmonar.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the effect of macitentan 10 mg as compared to placebo on:
    – Daily physical activity
    – Quality of life
    – Worsening of heart failure
    Evaluar el efecto de 10 mg de macitentan en comparación con placebo en:
    – La actividad física diaria
    – La calidad de vida
    – El empeoramiento de la insuficiencia cardíaca
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signs or symptoms of heart failure requiring treatment with at least one oral diuretic (any type)
    2. LVEF ≥ 40% (by echocardiography at screening)
    3. NYHA FC II to III
    4. Subjects with at least one of the following:
    a. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting > 12 hours and/or including i.v. diuretics at a healthcare facility) within 12 months prior to Screening
    b. Cardiac catheterization performed within 6 months prior to Screening showing end-expiratory PAWP or LVEDP > 15 mmHg
    c. Patients with structural heart disease defined as either one of the following by echocardiography at Screening:
    i. Left atrial (LA) enlargement:
    • Left atrial volume (LAV) > 58 ml (male) / > 52 ml (female) or
    • Left atrial volume index (LAVI) ≥ 28 ml/m2, or
    • LA area > 20 cm2, or
    • LA diameter > 4.0 cm (male) / > 3.8 cm (female)
    ii. Left ventricular septal thickness or posterior wall thickness >= 1.1 cm
    5. Elevated NT-proBNP / BNP: ≥ 250 / 75 pg/mL for subjects in sinus rhythm or ≥ 1000 / 300 pg/mL for subjects with atrial fibrillation (AF) at any time within 3 months prior to Screening
    6. Pulmonary vascular disease or RV dysfunction meeting at least one of the following echocardiographic (at screening) and/or right heart catheterization (RHC) parameters (within 6 months prior to Screening):
    a. Echocardiographic peak TR velocity > 2.8 m/s or invasive mPAP ≥ 25 mmHg or invasive PASP > 40 mmHg (RHC) and evidence of RV dysfunction (TAPSE < 17 mm or RV fractional area change < 35% or RV tissue Doppler s’ velocity < 9.5 cm/s)
    b. Diastolic Pulmonary Vascular Pressure Gradient (DPG) > 5 mmHg (RHC)
    c. PVR > 3 Wood Units (RHC)
    1. Signos o síntomas de insuficiencia cardíaca que requieran tratamiento con al menos un diurético oral (de cualquier tipo).
    2. Fracción de eyección ventricular izquierda (FEVI) ≥40 % (por ecocardiografía en la selección).
    3. Clase II a III en la evaluación funcional de la New York Heart Association (NYHA).
    4. Pacientes con al menos uno de los siguientes:
    a. Hospitalización por insuficiencia cardíaca (siendo la insuficiencia cardíaca el principal motivo de la hospitalización o un tratamiento para la insuficiencia cardíaca de más de 12 horas de duración o que incluya diuréticos intravenosos (i.v.) en un centro sanitario) en los 12 meses anteriores a la selección.
    b. Cateterismo cardíaco llevado a cabo en los 6 meses anteriores a la selección que muestre una presión de enclavamiento pulmonar (PEAP) telespiratoria o una presión ventricular izquierda telediastólica (PVITD) >15 mmHg.
    c. Pacientes con cardiopatía estructural definida mediante ecocardiografía en la selección de una de las maneras siguientes:
    i. Crecimiento auricular izquierdo:
    • Volumen auricular izquierdo >58 ml (hombres)/52 ml (mujeres); o
    • Índice de volumen auricular izquierdo ≥28 ml/m2; o
    • Área auricular izquierda >20 cm2; o
    • Diámetro auricular izquierdo >4,0 cm (hombres)/3,8 cm (mujeres).
    ii. Grosor del tabique ventricular izquierdo o grosor de la pared posterior ≥1,1 cm.
    5. NT-proBNP/BNP elevado: ≥250/75 pg/ml para pacientes en ritmo sinusal o ≥1000/300 pg/ml para pacientes con fibrilación auricular (FA) en cualquier momento en los 3 meses anteriores a la selección.
    6. Vasculopatía pulmonar o disfunción ventricular derecha (VD) con al menos uno de los siguientes parámetros ecocardiográficos (en la selección) o de cateterismo cardíacoderecho (CCD) (en los 6 meses anteriores a la selección):
    a. Velocidad pico de insuficiencia tricuspídea (IT) en ecocardiografía >2,8 m/s o presión arterial pulmonar media (PAPm) invasiva ≥25 mmHg o presión sistólica de la arteria pulmonar (PSAP) invasiva >40 mmHg (CCD) e indicios de disfunción VD (TAPSE <17 mm o cambio de área fraccional VD <35 % o velocidad Doppler tisular VD <9,5 cm/s).
    b. Gradiente de presión vascular pulmonar diastólica (GPD) >5 mmHg (CCD).
    c. Resistencia vascular pulmonar (RVP) >3 unidades Wood (CCD).
    E.4Principal exclusion criteria
    1. Any prior measurement of LVEF < 40%.
    Cardiovascular comorbidities:
    2. Significant unrepaired structural valvular heart disease (i.e., greater than mild aortic or mitral stenosis, and greater than moderate aortic or mitral regurgitation).
    3. Hypertrophic, restrictive, and infiltrative cardiomyopathies.
    4. Pericardial disease.
    5. Acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) or unstable coronary artery disease or has undergone coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening.
    6. Known indication for PCI or CABG.
    7. Uncontrolled heart rate (HR) from atrial fibrillation or atrial flutter (> 110 beats per minute) as assessed by ECG.
    8. History of serious life-threatening or hemodynamically significant arrhythmias, including symptomatic or sustained ventricular tachycardia or defibrillator shock within 12 month(s) of Screening.
    9. History of or anticipated heart transplant or anticipated/implanted ventricular assist device.
    10. Transient ischemic attack (TIA) or stroke within 3 months of Screening.
    11. Systolic blood pressure (SBP) ≥ 180 mmHg1 or diastolic blood pressure (DBP) ≥ 110 mmHg.
    Other causes of right heart failure not associated with left ventricular dysfunction:
    12. Significant parenchymal lung disease fulfilling any of the following:
    a. Forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC ratio) < 0.7 associated with FEV1 < 50% of predicted value after bronchodilator administration
    b. Known moderate or severe restrictive lung disease, e.g., total lung capacity (TLC) < 60% (predicted)
    c. Clinical suspicion of diffuse interstitial fibrosis or alveolitis, unless excluded by high resolution computed tomography (CT)
    d. Clinical suspicion of pulmonary thromboembolism within 12 months prior to Screening, unless excluded by ventilation/perfusion (V/Q) scan or computed tomography angiography (CTA)
    13. Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula.
    14. Known and documented severe hepatic impairment, e.g., Child Pugh Class C.
    15. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 3 × the upper limit of normal (ULN) at Screening.
    16. Hemoglobin < 100g/L (< 10 g/dl) at Screening.
    Relacionados con la enfermedad
    1. Cualquier medición de FEVI anterior <40 %.
    Enfermedades cardiovasculares concomitantes:
    2. Valvulopatía cardíaca estructural significativa no solucionada (es decir, mayor que una estenosis aórtica o mitral leve y mayor que una insuficiencia valvular aórtica o mitral moderada).
    3. Miocardiopatías hipertróficas, restrictivas e infiltrantes.
    4. Enfermedad pericárdica.
    5. Síndrome coronario agudo, incluido infarto de miocardio con elevación del segmento ST (IMEST), infarto de miocardio sin elevación del segmento ST (IMSEST) o arteriopatía coronaria inestable o se ha sometido a cirugía de revascularización coronaria (CABG) o a una intervención coronaria percutánea (ICP) en los 3 meses previos a la selección.
    6. Indicación conocida de ICP o CABG.
    7. Frecuencia cardíaca (FC) no controlada por fibrilación auricular o aleteo auricular (>110 latidos por minuto) según evaluación con ECG.
    8. Antecedentes de arritmias graves potencialmente mortales o hemodinámicamente significativas, incluidos taquicardia ventricular sostenida o sintomática o desfibrilación en los 12 meses previos a la selección.
    9. Antecedentes de trasplante de corazón anticipado o dispositivo de asistencia ventricular anticipado/implantado.
    10. Accidente isquémico transitorio (AIT) o accidente cerebrovascular en los 3 meses previos a la selección.
    11. Presión arterial sistólica (PAS) ≥180 mm/Hg o presión arterial diastólica (PAD) ≥110 mmHg.
    Otras causas de insuficiencia cardíaca derecha no asociadas con la disfunción ventricular izquierda:
    12. Neumopatía parenquimatosa significativa que cumpla alguno de los siguientes:
    a. Volumen espiratorio forzado en el primer segundo/capacidad vital forzada (relación VEF1/CVF) <0,7 asociada a VEF1 <50 % del valor previsto después de la administración de un broncodilatador.
    b. Neumopatía restrictiva moderada o grave conocida, por ej., capacidad pulmonar total (CPT) <60 % (prevista).
    c. Sospecha clínica de alveolitis o fibrosis intersticial difusa, a menos que se excluyan mediante tomografía computarizada (TAC) de alta resolución.
    d. Sospecha clínica de tromboembolia pulmonar en los 12 meses previos a la selección, a menos que se excluya tras gammagrafía de ventilación/perfusión (V/Q) o angiografía por tomografía computarizada (ATC).
    13. Disfunción renal grave con una tasa de filtración glomerular estimada (TFGe) <30 ml/min por 1,73 m2 calculada según la fórmula de modificación de dieta en la enfermedad renal (MDRD).
    14. Insuficiencia hepática conocida y documentada, por ej., Child-Pugh de clase C.
    15. Aspartato aminotransferasa (ASAT) o alanina aminotransferasa (ALAT) ≥3 veces el límite superior de la normalidad en la selección.
    16. Hemoglobina <100 g/l (<10 g/dl) en la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint(s)
    • Percent of baseline NT-proBNP assessed at Week 24
    Criterios principales de valoración de la eficacia
    • Porcentaje del NT-proBNP basal evaluado en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    • Change from baseline to Week 24 in accelerometer-assessed proportion of time spent in light to vigorous physical activity based on a threshold of > 100 activity counts per minute
    • Change from baseline to Week 24 in the clinical summary score (as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ])
    • Time to worsening heart failure (WHF) event over 52 weeks
    Criterios secundarios de valoración de la eficacia
    • Cambio desde el momento basal hasta la semana 24 en la proporción de tiempo, evaluada con acelerómetro, dedicada a la actividad física de ligera a intensa a partir de un umbral >100 recuentos de actividad por minuto.
    • Cambio desde el momento basal hasta la semana 24 en la puntuación del resumen clínico (según evaluación del cuestionario de cardiomiopatía de Kansas City [KCCQ]).
    • Tiempo hasta el acontecimiento de empeoramiento de la insuficiencia cardíaca (EIC) a lo largo de 52 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24, Week 52
    Semana 24, Semana 52
    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 No
    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 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 EEA49
    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
    Australia
    Austria
    Bulgaria
    China
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    United Kingdom
    United States
    Vietnam
    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
    Safety follow-up period or, if applicable, Post-treatment observation period have been completed.
    Se ha completado el período de seguimiento de la seguridad o, si procede, el período de observación posterior al tratamiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 300
    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)
    The investigator/delegate will explain to subjects what treatment(s) / medical care is necessary and available according to local regulations.
    El investigador / delegado explicará a los sujetos qué tratamiento (s) / atención médica es necesario y disponible de acuerdo con las regulaciones locales.
    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 Decision2017-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-12
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