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    Summary
    EudraCT Number:2016-002299-28
    Sponsor's Protocol Code Number:20110203
    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:2016-11-03
    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 number2016-002299-28
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
    Estudio doble ciego, aleatorizado, controlado con placebo y multicéntrico para evaluar la eficacia y la seguridad de omecamtiv mecarbil en la mortalidad y morbilidad de sujetos con insuficiencia cardíaca crónica con fracción de eyección reducida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the use of Omecamtiv Mecarbil on subjects with heart failure
    Estudio para investigar el uso de Omecamtiv Mecarbil en sujetos con insuficiencia cardíaca
    A.3.2Name or abbreviated title of the trial where available
    GALACTIC-HF
    A.4.1Sponsor's protocol code number20110203
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34900850153
    B.5.6E-mailMedinfoInternational@amgen.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 nameOmecamtiv mecarbil
    D.3.2Product code AMG 423
    D.3.4Pharmaceutical form 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 INNOmecamtiv Mecarbil
    D.3.9.1CAS number 873697-71-3
    D.3.9.2Current sponsor codeAMG 423
    D.3.9.3Other descriptive nameOMECAMTIV MECARBIL
    D.3.9.4EV Substance CodeSUB79172
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameOmecamtiv mecarbil
    D.3.2Product code AMG 423
    D.3.4Pharmaceutical form 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 INNOmecamtiv Mecarbil
    D.3.9.1CAS number 873697-71-3
    D.3.9.2Current sponsor codeAMG 423
    D.3.9.3Other descriptive nameOMECAMTIV MECARBIL
    D.3.9.4EV Substance CodeSUB79172
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    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: 3
    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 nameOmecamtiv mecarbil
    D.3.2Product code AMG 423
    D.3.4Pharmaceutical form 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 INNOmecamtiv Mecarbil
    D.3.9.1CAS number 873697-71-3
    D.3.9.2Current sponsor codeAMG 423
    D.3.9.3Other descriptive nameOMECAMTIV MECARBIL
    D.3.9.4EV Substance CodeSUB79172
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboTablet
    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
    Chronic Heart Failure With Reduced Ejection Fraction
    Insuficiencia cardíaca crónica con fracción de eyección reducida
    E.1.1.1Medical condition in easily understood language
    Chronic 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    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 evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on the time to cardiovascular (CV) death or first HF event, whichever occurs first, in subjects with chronic HF with reduced ejection fraction (HFrEF) receiving standard of care (SoC) therapy.

    An HF event is defined as presentation of the patient for an urgent, unscheduled clinic/office/ED visit, or hospital admission, with a primary diagnosis of HF, where the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF (Hicks et al, 2015). Changes to oral diuretic therapy do not qualify as initiation or intensification of treatment.
    Evaluar el efecto del tratamiento con omecamtiv mecarbil (OM) en comparación con placebo en el tiempo hasta la muerte cardiovascular (CV) o el primer acontecimiento de IC, lo que ocurra antes, en sujetos con IC crónica con fracción de eyección reducida (ICFER) que reciben tratamiento estándar (SOC).

    Un acontecimiento de IC se define como la visita urgente y sin programar de un paciente al centro, la consulta o el servicio de urgencias, o su ingreso hospitalario, con un diagnóstico primario de IC, donde dicho paciente presenta síntomas nuevos o que empeoran de IC en el momento de la visita, muestra evidencia objetiva de IC nueva o agravada y se inicia o intensifica el tratamiento específico para la IC (Hicks et al., 2015).Los cambios en el tratamiento diurético por vía oral no se consideran como inicio o intensificación del tratamiento.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of OM on time to:
    - CV death
    - HF hospitalization
    - all-cause death

    To evaluate the effects of treatment with OM on change in patient-reported outcomes (PROs).
    Evaluar los efectos de OM en el tiempo hasta la:
    -muerte CV,
    -hospitalización por IC,
    -muerte por cualquier causa.
    Evaluar los efectos del tratamiento con OM en el cambio en los resultados notificados por el
    paciente (PRO).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject has provided informed consent

    Male or female, ≥ 18 to ≤ 85 years of age

    History of chronic HF

    LVEF ≤ 35%

    NYHA class II to IV

    Managed with HF SoC therapies consistent with regional clinical practice guidelines

    Current hospitalization with primary reason of HF or prior HF hospitalization, or urgent HF admission to emergency department (ED) within 1 year prior to screening

    BNP level ≥ 125 pg/mL or an NT-proBNP level ≥ 400 pg/mL at most recent screening assessment (for subjects with atrial fibrillation, the cut off levels are: BNP ≥ 375 pg/mL or NT proBNP ≥ 1200 pg/mL)
    -El sujeto ha dado su consentimiento informado
    -Hombre o mujer de ≥ 18 a ≤ 85 años de edad
    -Antecedentes de IC crónica (definida como la necesidad de tratamiento para la IC durante un período mínimo de 30 días antes de la aleatorización)
    -FEVI ≤ 35%, según la historia clínica más reciente del sujeto, no en el contexto de una descompensación aguda
    -Clase II a IV de la NYHA en la evaluación de selección más reciente
    -Tratamiento de la IC con tratamientos SOC de conformidad con las directrices de práctica clínica regionales según el criterio del investigador en cuanto al estado clínico del sujeto
    -Estar hospitalizado principalmente por IC o haber estado hospitalizado previamente por IC, o haber ingresado por IC en el servicio de urgencias durante el año anterior a la selección
    -Un nivel de péptido natriurético tipo B (BNP) ≥ 125 pg/mL o un nivel de NTproBNP ≥ 400 pg/mL en la evaluación de selección más reciente (los sujetos que reciben un inhibidor de la neprilisina y del receptor de angiotensina [ARNi] deben utilizar una evaluación NT-proBNP; los niveles de corte de los sujetos con fibrilación auricular son los siguientes: BNP ≥ 375 pg/mL o NTproBNP≥ 1.200 pg/mL)
    E.4Principal exclusion criteria
    Inability to swallow study medication tablet

    Receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to randomization

    Receiving IV inotropes or IV vasopressors ≤ 3 days prior to randomization

    Receiving IV diuretics or IV vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to randomization
    Acute coronary syndrome, stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 3 months prior to randomization

    Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease

    Routinely scheduled outpatient intravenous infusions for HF (eg, inotropes, vasodilators, diuretics) or routinely scheduled ultrafiltration

    Systolic blood pressure > 140 mmHg or < 85 mmHg, or diastolic blood pressure > 90 mmHg, or heart rate > 110 beats per minute, or < 50 beats per minute at screening

    Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2
    -Incapacidad para tragar los comprimidos de la medicación en estudio (p. ej.,
    trastornos de deglución, sondas de alimentación)
    -Haber recibido soporte hemodinámico mecánico (p. ej., bomba de balón de
    contrapulsación intraaórtico) o ventilación mecánica (incluida la ventilación mecánica no invasiva, es decir, dispositivos de presión positiva de doble nivel en las vías respiratorias [BiPAP] o de presión positiva continua en las vías respiratorias [CPAP]) ≤ 7 días antes de la aleatorización
    -Haber recibido inotrópicos (p. ej., dobutamina, milrinona o levosimendán) o
    vasopresores (p. ej., epinefrina, noradrenalina, dopamina o vasopresina) por vía intravenosa ≤ 3 días antes de la aleatorización
    -Haber recibido diuréticos o vasodilatadores por vía intravenosa o tratamiento
    complementario con oxígeno ≤ 12 horas antes de la aleatorización
    -Síndrome coronario agudo (infarto de miocardio con elevación del segmento ST,
    infarto de miocardio sin elevación del segmento ST, angina inestable), infarto
    cerebral o accidente isquémico transitorio, cirugía cardíaca mayor, intervención
    coronaria percutánea o valvuloplastia en los 3 meses previos a la aleatorización
    -Valvulopatía coronaria grave no corregida o miocardiopatía hipertrófica obstructiva, miocarditis activa, pericarditis constrictiva o cardiopatía congénita clínicamente significativa
    -Infusiones intravenosas ambulatorias programadas de forma rutinaria para la IC
    (p. ej., inotrópicos, vasodilatadores [p. ej., nesiritida], diuréticos) o ultrafiltración
    programada de forma rutinaria
    -Presión arterial sistólica > 140 mmHg o < 85 mmHg, o presión arterial diastólica
    > 90 mmHg, o frecuencia cardíaca > 110 latidos por minuto, o < 50 latidos por
    minuto en el momento de la selección
    -Tasa de filtración glomerular estimada (eGFR) < 20 mL/min/1,73 m2 o estar
    recibiendo diálisis en el momento de la selección
    -Ver protocolo para otros criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    Composite of time to CV death or first HF event, whichever occurs first.
    Compuesta de tiempo hasta la muerte CV o hasta el primer acontecimiento de IC, lo que
    ocurra antes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of trial
    Duración del ensayo
    E.5.2Secondary end point(s)
    Time to CV death.
    Change in Kansas City Cardiomyopathy Questionnaire Total Symptoms Score (KCCQ TSS) from baseline to Week 24.
    Time to first HF hospitalization.
    Time to all-cause death.
    - tiempo hasta la muerte CV,
    -cambio en la puntuación total de los síntomas (TSS, Total Symptoms Score) del Kansas City Cardiomyopathy Questionnaire (KCCQ) desde el nivel basal hasta la semana 24,
    -tiempo hasta la primera hospitalización por IC,
    -tiempo hasta muerte por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of trial
    Duración del ensayo
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA318
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Japan
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    Ukraine
    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
    The end of study is when the last subject has completed the end of study assessments.
    El fin de estudio será cuando el último paciente haya completado las evaluaciones de fin de estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 7457
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 828
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4191
    F.4.2.2In the whole clinical trial 8285
    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 Decision2017-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-14
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