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    Summary
    EudraCT Number:2018-004565-14
    Sponsor's Protocol Code Number:20170625
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-004565-14
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar el impacto de evolocumab sobre los acontecimientos cardiovasculares mayores en pacientes con riesgo cardiovascular elevado sin infarto de miocardio o ictus previo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
    Efecto de evolocumab en pacientes con riesgo cardiovascular elevado sin infarto de miocardio o ictus previo
    A.4.1Sponsor's protocol code number20170625
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03872401
    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 pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6301
    B.5.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Repatha 140 mg solution for injection in pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameEvolocumab
    D.3.2Product code AMG145
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEVOLOCUMAB
    D.3.9.2Current sponsor codeAMG 145
    D.3.9.4EV Substance CodeSUB128552
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dyslipidemia
    Dislipidemia
    E.1.1.1Medical condition in easily understood language
    Abnormal amounts of lipids in the blood
    Cantidades inusuales de lípidos en sangre
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    E.1.2System Organ Class 100000004861
    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 evolocumab, compared with placebo, on the risk for coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first, in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy.
    -To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first, in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy.
    • Evaluar el efecto del tratamiento con evolocumab, en comparación con placebo, sobre el riesgo de muerte por cardiopatía coronaria (CC), infarto de miocardio (IM) o ictus isquémico, lo que ocurra primero, en sujetos con riesgo cardiovascular elevado sin IM o ictus previo que reciben tratamiento hipolipemiante optimizado.
    • Evaluar el efecto del tratamiento con evolocumab, en comparación con placebo, sobre el riesgo de muerte por CC, IM, ictus isquémico o cualquier revascularización arterial por isquemia, lo que ocurra primero, en sujetos con riesgo cardiovascular elevado sin IM o ictus previo que reciben tratamiento hipolipemiante optimizado.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for:
    1. MI, ischemic stroke, or any ischemia driven arterial revascularization;
    2. CHD death, MI, or any ischemia-driven arterial revascularization;
    3. cardiovascular death, MI, or stroke;
    4. MI;
    5. any ischemia-driven arterial revascularization;
    6. CHD death;
    7. cardiovascular death;
    8. all cause of death;
    9. ischemic stroke;

    in subjects at high cardiovascular risk without prior MI or stroke and receiving optimized lipid-lowering therapy.
    •Evaluar el efecto del tratamiento con evolocumab, en comparación con placebo, sobre el riesgo de:
    1.IM, ictus isquémico o cualquier revascularización arterial por isquemia;
    2.Muerte por CC, IM o cualquier revascularización arterial por isquemia;
    3.Muerte cardiovascular, IM o ictus;
    4.IM;
    5.Cualquier revascularización arterial por isquemia;
    6.Muerte por CC;
    7.Muerte cardiovascular;
    8.Muerte por cualquier causa;
    9.Ictus isquémico;

    en sujetos con riesgo cardiovascular elevado sin IM o ictus previo que reciben tratamiento hipolipemiante optimizado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    -Subject has provided informed consent prior to initiation of any study specific activities/procedures

    -Adult subjects ≥ 50 years (men) or ≥ 55 years (women) to < 80 years of age (either sex)

    -Subjects must have an LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) or non-HDL-C ≥ 130 mg/dL (≥ 3.4 mmol/L) at screening, after ≥ 4 weeks of optimized lipid-lowering therapy

    -Diagnostic evidence of at least 1 of the following (A – D) at screening:

    A. Significant coronary artery disease meeting at least 1 of the following criteria:
    1. History of coronary revascularization with multi-vessel coronary disease as evidenced by any of the following:
    (a) multi-vessel percutaneous coronary intervention (PCI)
    (b) PCI or coronary artery bypass grafting (CABG) with residual ≥50% stenosis in a separate, unrevascularized segment or vessel, or
    (c) multi-vessel CABG at least 5 years prior to screening
    2. Significant coronary disease without prior revascularization as evidenced by either a ≥ 70% stenosis of at least 1 coronary artery, ≥ 50% stenosis of 2 or more coronary arteries, or ≥ 50% stenosis of the left main coronary artery
    3. known coronary artery calcium score ≥ 100

    B. Significant atherosclerotic cerebrovascular disease meeting at least 1 of the following criteria:
    1. prior transient ischemic attack with ≥ 50% carotid stenosis
    2. carotid artery stenosis of ≥ 70% or 2 or more ≥ 50% stenosis
    3. prior carotid artery revascularization

    C. Significant peripheral arterial disease meeting at least 1 of the following criteria:
    1. ≥ 50% stenosis in a limb artery
    2. history of abdominal aorta treatment (percutaneous and surgical)
    3. ankle brachial index (ABI) < 0.85

    D. Diabetes mellitus with at least 1 of the following:
    1. known microvascular disease, defined by diabetic nephropathy or treated retinopathy. Diabetic nephropathy defined as microalbuminuria (urinary albumin to creatinine ratio ≥ 30mg/g) and/or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
    2. chronic treatment with insulin
    3. diabetes diagnosis ≥ 10 years ago

    - At least 1 of the following high risk criteria at screening (most recent lab values prior to screening, as applicable):
    1. polyvascular disease, defined as coronary, carotid, or peripheral artery stenosis ≥ 50% in a second distinct vascular location in a patient with coronary, cerebral or peripheral arterial disease (above inclusion criterion A-C)
    2. diabetes or known evidence of metabolic syndrome in a subject with coronary, cerebral, or peripheral artery disease (above inclusion
    criterion A-C)
    3. at least 1 coronary, carotid, or peripheral artery stenosis of ≥ 50% in a patient with diabetes meeting above inclusion criterion D
    4. LDL ≥ 130 mg/dL ( ≥ 3.4 mmol/L) or non-HDL ≥ 160 mg/dL (> 4.2 mmol/L)
    5. lipoprotein (a) > 125 nmol/L (50 mg/dL)
    6. known familial hypercholesterolemia
    7. family history of premature coronary artery disease defined as an MI or CABG in the subject’s father or brother at age < 55 years or an MI or CABG in the subject’s mother or sister at age < 60 years
    8. high sensitive c-reactive protein ≥ 3.0 mg/dL
    9. current tobacco use
    10. ≥ 65 years of age
    11. menopause before 40 years of age
    12. eGFR 15 to < 45 mL/min/1.73 m2
    Principales criterios de inclusión:
    -El sujeto ha proporcionado su consentimiento informado antes de iniciar cualquier procedimiento/actividad específicos del estudio.

    -Sujetos adultos de ≥ 50 (hombres) o ≥ 55 (mujeres) a < 80 años de edad (cualquier sexo).

    -Los sujetos deben presentar un nivel de C-LDL ≥ 100 mg/dl (≥ 2,6 mmol/l) o de C-no-HDL ≥ 130 mg/dl (≥ 3,4 mmol/l) en la selección, después de ≥ 4 semanas de tratamiento hipolipemiante optimizado

    -Evidencia diagnóstica de al menos 1 de las siguientes enfermedades (A - D) en la selección:

    A. Arteriopatía coronaria significativa que cumple al menos 1 de los siguientes criterios:
    1. Antecedentes de revascularización coronaria con enfermedad coronaria multivaso, demostrada por alguno de los siguientes criterios:
    a) Intervención coronaria percutánea (ICP) multivaso.
    b) ICP o injerto de derivación de arteria coronaria (IDAC) con estenosis residual ≥ 50% en un segmento o vaso distinto no revascularizado.
    c) IDAC multivaso al menos 5 años antes de la selección.
    2. Enfermedad coronaria significativa sin revascularización previa, demostrada por una estenosis ≥ 70% de al menos 1 arteria coronaria, una estenosis ≥ 50% de 2 o más arterias coronarias o una estenosis ≥ 50% de la arteria coronaria principal izquierda.
    3. Puntuación conocida del calcio arterial coronario ≥ 100.

    B. Enfermedad cerebrovascular aterosclerótica significativa que cumple al menos 1 de los siguientes criterios:
    1. Accidente isquémico transitorio previo con estenosis carotídea ≥ 50%.
    2. Estenosis ≥ 70% de la arteria carótida o 2 o más estenosis ≥ 50%.
    3. Revascularización previa de la arteria carótida.

    C. Arteriopatía periférica significativa que cumple al menos 1 de los siguientes criterios:
    1. Estenosis ≥ 50% en una arteria de las extremidades.
    2. Antecedentes de tratamiento (percutáneo o quirúrgico) de la aorta abdominal.
    3. Índice tobillo-brazo (ITB) < 0,85.

    D. Diabetes mellitus que cumple al menos 1 de los siguientes criterios:
    1. Enfermedad microvascular conocida, definida como nefropatía diabética o retinopatía tratada. Nefropatía diabética, definida como microalbuminuria (cociente albúmina/creatinina en orina ≥ 30mg/g) y/o tasa de filtración glomerular estimada (TFGe) < 60 ml/min/1,73 m2.
    2. Tratamiento crónico con insulina.
    3. Diagnóstico de diabetes hace ≥ 10 años.

    - Cumplir al menos 1 de los siguientes criterios de alto riesgo en la selección (valores analíticos más recientes antes de la selección, según corresponda):
    1. Enfermedad polivascular, definida como una estenosis coronaria, carotídea o arterial periférica ≥ 50% en una segunda localización vascular distinta en un paciente con arteriopatía coronaria, cerebral o periférica (A, B o C arriba).
    2. Diabetes o evidencia conocida de síndrome metabólico en un sujeto con arteriopatía coronaria, cerebral o periférica (A, B o C arriba).
    3. Al menos 1 estenosis coronaria, carotídea o arterial periférica ≥ 50% en un paciente con diabetes que cumple los criterios de inclusión (D arriba).
    4. LDL ≥ 130 mg/dl (≥ 3,4 mmol/l) o C-no-HDL ≥ 160 mg/dl (> 4,2 mmol/l).
    5. Lipoproteína(a) > 125 nmol/l (50 mg/dl).
    6. Hipercolesterolemia familiar conocida.
    7. Antecedentes familiares de arteriopatía coronaria prematura, definida como un IM o IDAC en el padre o un hermano del sujeto a la edad de < 55 años o un IM o IDAC en la madre o una hermana del sujeto a la edad de < 60 años.
    8. Proteína C reactiva de alta sensibilidad ≥ 3,0 mg/l.
    9. Tabaquismo actual.
    10. Edad ≥ 65 años.
    11. Menopausia antes de los 40 años de edad.
    12. TFGe entre 15 y < 45 ml/min/1,73 m2.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria apply:
    1. Disease Related
    - MI or stroke prior to randomization
    - CABG < 3 months prior to screening
    - Uncontrolled or recurrent ventricular tachycardia
    - Atrial fibrillation not on anticoagulation therapy
    - Uncontrolled hypertension (sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at screening
    - Last measured left-ventricular ejection fraction < 30% or New York Heart Association (NYHA) Functional Class III/IV
    2. Diagnostic Assessments
    - Fasting triglycerides ≥500 mg/dL (5.7 mmol/L) at screening
    - End stage renal disease (ESRD), defined as an eGFR < 15 mL/min/1.73 m2 or receiving dialysis at screening
    3. Other Medical Conditions
    - Malignancy, except non-melanoma skin cancers, or in situ cancers of the cervix, prostate, or breast duct within 5 years prior to screening
    - History or evidence of clinically significant disease (eg, malignancy, respiratory, gastrointestinal, renal or psychiatric disease) or unstable disorder that, in the opinion of the investigator(s), Amgen physician or designee would pose a risk to the patient’s safety or interfere with the study assessments, procedures, completion, or result in a life expectancy of less than 1 year
    4. Prior/Concomitant Therapy
    - Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
    - Previously received a cholesterol ester transfer protein (CETP) inhibitor (ie, anacetrapib, dalcetrapib, evacetrapib), mipomersen, lomitapide, or has undergone LDL-apheresis in the last 12 months prior to LDL-C screening
    5. Prior/Concurrent Clinical Study Experience
    - Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).
    6. Other Exclusions
    - Female subject is pregnant, had a positive pregnancy test at screening, breastfeeding, or planning to become pregnant or breastfeed during treatment and for an additional 15 weeks after the last dose of investigational product.
    - Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of investigational product.
    - Subject has known sensitivity to any of the products or components to be administered during dosing.
    - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge.
    - Subject is staff personal directly involved with the study or is a family member of the investigational study staff
    Los sujetos excluidos del estudio seran aquellos que cumplan alguno de los siguientes criterios:
    1. Relacionados con la enfermedad
    - IM o ictus antes de la aleatorización
    - IDAC < 3 meses antes de la selección.
    - Taquicardia ventricular no controlada o recurrente.
    - Fibrilación auricular sin tratamiento anticoagulante.
    - Hipertensión no controlada (presión arterial sistólica > 180 mmHg o presión arterial diastólica > 110 mmHg en reposo) en la selección.
    - Última medición de la fracción de eyección ventrícular izquierda < 30% o clase funcional III/IV de la New York Heart Association (NYHA).
    2. Evaluaciones diagnósticas
    - Triglicéridos en ayunas ≥ 500 mg/dl (5,7 mmol/l) en la selección.
    - Enfermedad renal en fase terminal (ERT), definida como una TFGe < 15 ml/min/1,73 m2 o estar sometido a diálisis en la selección.
    3. Otras enfermedades
    - Tumor maligno, excepto cáncer de piel no melanomatoso o cánceres in situ de cérvix, próstata o ductal de mama en los 5 años previos a la aleatorización.
    - Antecedentes o evidencia de una enfermedad o trastorno inestable clínicamente significativos (p. ej., tumor maligno o enfermedad respiratoria, gastrointestinal, renal o psiquiátrica) que, en opinión de los investigadores, el médico de Amgen o la persona designada, pudieran suponer un riesgo para la seguridad del paciente o interferir en las evaluaciones, los procedimientos o la realización del estudio o dar lugar a una esperanza de vida inferior a 1 año.
    4. Tratamiento previo/concomitante
    - Haber recibido previamente o estar recibiendo evolocumab o cualquier otro tratamiento para inhibir la PCSK9.
    - Haber recibido previamente un inhibidor de la proteína de transferencia de ésteres del colesterol (CETP) (es decir, anacetrapib, dalcetrapib, evacetrapib), mipomersen o lomitapida o haberse sometido a aféresis de LDL en los últimos 12 meses previos a la determinación del C-LDL de selección.
    5. Experiencia previa/concomitante en ensayos clínicos
    - Estar recibiendo actualmente tratamiento en otro estudio de un fármaco o producto sanitario en investigación o que hayan transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de un fármaco o producto sanitario en investigación.
    6. Otras exclusiones
    - Mujeres embarazadas, con una prueba de embarazo positiva en la selección, que den el pecho o que planeen quedarse embarazadas o dar el pecho durante el tratamiento y durante las 15 semanas posteriores a la última dosis del producto en investigación.
    - Mujeres en edad fértil que no quieran utilizar un método anticonceptivo eficaz que sea aceptable durante el tratamiento y durante las 15 semanas posteriores a la última dosis del producto en investigación. Consulte el apartado 12.5 para obtener más información sobre métodos anticonceptivos.
    - El sujeto tiene sensibilidad conocida a alguno de los productos o componentes que se vayan a administrar durante el tratamiento del estudio.
    - Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos requeridos por el estudio.
    - El sujeto es un miembro del estudio directamente implicado en su realización o es familiar de un miembro del estudio de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    - Time to CHD death, MI, or ischemic stroke, whichever occurs first
    - Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first
    - Tiempo hasta la muerte por CC, IM o ictus isquémico, lo que ocurra primero.
    - Tiempo hasta la muerte por CC, IM, ictus isquémico o cualquier revascularización arterial por isquemia, lo que ocurra primero.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continually during treatment period and at EOS
    Continuamente durante el periodo de tratamiento y al final del estudio
    E.5.2Secondary end point(s)
    - Time to MI, ischemic stroke, or any ischemia-driven arterial revascularization
    - Time to CHD death, MI, or any ischemia-driven arterial revascularization
    - Time to cardiovascular death, MI, or stroke
    - Time to MI
    - Time to any ischemia-driven arterial revascularization
    - Time to CHD death
    - Time to cardiovascular death
    - Time to all cause of death
    - Time to ischemic stroke
    - Tiempo hasta el IM, ictus isquémico o cualquier revascularización arterial por isquemia.
    - Tiempo hasta la muerte por CC, IM o cualquier revascularización arterial por isquemia.
    - Tiempo hasta la muerte cardiovascular, IM o ictus.
    - Tiempo hasta el IM.
    - Tiempo hasta cualquier revascularización arterial por isquemia.
    - Tiempo hasta la muerte por CC.
    - Tiempo hasta la muerte cardiovascular.
    - Tiempo hasta la muerte por cualquier causa.
    - Tiempo hasta el ictus isquémico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continually during treatment period and at EOS
    Continuamente durante el periodo de tratamiento y al final del estudio
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    cardiovascular outcomes study
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA350
    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
    Bulgaria
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    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 del último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 7215
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5785
    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 state370
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6500
    F.4.2.2In the whole clinical trial 13000
    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)
    Subjects may be eligible for continued treatment with Amgen investigational product(s) by an extension protocol or as provided for by the local country’s regulatory mechanism. However, Amgen reserves the unilateral right, at its sole discretion, to determine whether to supply Amgen investigational product(s) and by what mechanism, after termination of the study and before the product(s) is/are available commercially.
    Los sujetos sera elegidos para continuar el tratamiento con el producto(s) en investigación de Amgen mediante una extensión del protocolo o proporcionado mediante la vía de regulación local. Sin embargo, Amgen se reserva el derecho unilateral, a su discreción, de determinar si suministrar o no el producto(s) en investigación y por qué vía hacerlo, después de finalizar el estudio y antes de que el producto(s) esté disponible comercialmente.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Synexus Limited
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Bioclinica
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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