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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-002167-33
    Sponsor's Protocol Code Number:BAY1142524/16673
    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:2016-09-09
    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 number2016-002167-33
    A.3Full title of the trial
    A randomized, double-blind multicenter study to assess the safety and efficacy of a six month oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with reduced left-ventricular ejection fraction (LVEF ≤ 45%) after acute myocardial infarction (CHIARA MIA 2)
    Ensayo multicéntrico, aleatorizado, doble ciego, comparado con placebo, para evaluar la eficacia y seguridad del tratamiento con un inhibidor de la quimasa (BAY 1142524), a una dosis oral de 25 mg BID durante 6 meses añadido al tratamiento estándar en pacientes con infarto agudo de miocardio y reducción de la fracción de eyección del ventrículo izquierdo (FEVI ≤ 45%)” (CHIARA MIA 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and efficacy of a six month oral treatment with a twice daily dose of BAY 1142524 in comparison to placebo in patients with reduced left-ventricular ejection fraction after acute myocardial infarction
    Un estudio para investigar la seguridad y eficacia de un tratamiento de seis meses con una dosis por vía oral dos veces al día de BAY 1142524 en comparación con el placebo en pacientes con fracción de eyección ventricular izquierda reducida después de un infarto agudo de miocardio
    A.3.2Name or abbreviated title of the trial where available
    Chymase inhibitor BAY 1142524 in left-ventricular dysfunction after acute myocardial infarction
    A.4.1Sponsor's protocol code numberBAY1142524/16673
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointClinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressBayer Clinical Trials Contact
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.6E-mailclinical-trials-contact@bayer.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 nameBAY1142524 25mg tablets
    D.3.2Product code BAY1142524
    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 INNnot yet assigned
    D.3.9.2Current sponsor codeBAY 1142524
    D.3.9.3Other descriptive nameBAY 1142524
    D.3.9.4EV Substance CodeSUB126182
    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.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
    Left-ventricular dysfunction after acute myocardial infarction
    Disfunción ventricular izquierda tras un infarto agudo de miocardio
    E.1.1.1Medical condition in easily understood language
    Left-ventricular dysfunction after acute myocardial infarction
    Disfunción ventricular izquierda tras un infarto agudo de miocardio
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 this study is to determine efficacy of BAY 1142524 by investigating the changes in LVEF, EDVI, and ESVI from baseline to 6 months after treatment with 25 mg of BAY 1142524 BID in comparison to placebo and on top of standard of care as measured by cardiac MRI
    El objetivo principal de este estudio es determinar la eficacia de BAY 1142524 investigando los cambios en la FEVI (fracción de eyección del ventrículo izquierdo), el EDVI (diámetro teleiastólico del ventrículo izquierdo) y el ESVI (diámetro telesistólico del ventrículo izquierdo) desde el inicio hasta los 6 meses después del tratamiento con 25 mg de BAY 1142524 2 v/d en comparación con placebo añadido al tratamiento habitual, determinado por RM cardíaca
    E.2.2Secondary objectives of the trial
    Secondary objective is to analyze safety and tolerability as evidenced by the incidence and severity of AEs
    El objetivo secundario es analizar la seguridad y la tolerabilidad probadas por la incidencia y la gravedad de los AA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with first ST elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) or thrombolysis within 24 h after symptom onset.
    2. Diagnosis of STEMI requires the presence of the following 3 criteria: * Typical clinical symptoms such as chest pain, shortness of breath for more than 20 min related to the myocardial infarction. * New ST elevation indicating myocardial infarction * Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and / or elevation of creatinine kinase (CK) and creatinine kinase MB (6-10% of CK-MB).
    3. At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size >10% LV mass (as measured by LGE-MRI, central blinded evaluation).
    1. Pacientes con un primer infarto de miocardio con elevación del segmento ST (IMEST) tratados con ICP (intervención coronaria percutánea) primaria o trombolisis en las 24 h después del inicio de los síntomas.
    2. El diagnóstico de IMEST requiere la presencia de los 3 criterios siguientes: *Síntomas clínicos habituales como dolor torácico, dificultad para respirar durante más de 20 minutos relacionada con el infarto de miocardio. *Nueva elevación del segmento ST en el punto J en dos derivaciones contiguas con los puntos de corte: ≥ 0,1 mV en todas las derivaciones excepto V2–V3, en las que se aplican los puntos de corte siguientes: ≥ 0,2 mV en varones o ≥ 0,15 mV en mujeres. *Una elevación significativa en la troponina T o I con al menos un valor por encima del límite superior de referencia (LSR) del percentil 99 y/o una elevación de la creatina quinasa y la creatina quinasa MB (6 %-10 % de la creatina quinasa total) según la práctica habitual.
    3. En el periodo de selección, en los días 5 a 9 tras el IM, los pacientes deben tener una FEVI ≤ 45 % y un tamaño del infarto >10 % de la masa ventricular izquierda tras el IMEST (determinado por RTG-RM, evaluación central con enmascaramiento).
    E.4Principal exclusion criteria
    1. Contraindication to perform MRI.
    2. LVEF < 20%.
    3. Previous MI, previous cardiac surgery such as CABG.
    4. History of heart failure or LVEF < 50% before occurrence of the first STEMI.
    5. Infarct size > 45% (g/g; LV mass) between 5 and 9 days after acute MI.
    6. NYHA class IV at randomization.
    7. Any planned cardiac intervention after baseline MRI or any other planned operations.
    8. Non-ischemic causes for cardiomyopathy
    9. Diagnosis of atrial Fibrillation
    10. Systolic blood pressure < 100 mmHg or > 180 mmHg; diastolic blood pressure < 50 mmHg or > 110 mmHg; heart rate < 50 or > 100 beats / min
    11. Most recent eGFR result since MI < 30 mL/min/1.73m2
    12. Clinically relevant hepatic dysfunction
    1. Contraindicación de una RM cardíaca.
    2. FEVI < 20 %.
    3. IM anterior, intervención quirúrgica cardíaca anterior como cirugía de revascularización coronaria.
    4. Antecedentes de insuficiencia cardíaca o FEVI < 50 % antes del primer IMEST.
    5. Tamaño del infarto > 45% (g/g; masa VI) en los días 5 a 9 tras el Infarto agudo de miocardio.
    6. Clase IV de la NYHA en la aleatorización.
    7. Cualquier intervención cardiaca planificada tras la RM inicial o cualquier otra intervención programada.
    8.Causas no isquémicas para la miocardiopatía
    9. Diagnóstico de fibrilación auricular
    10. Presión arterial sistólica < 100 mmHg o > 180 mmHg; presión arterial diastólica < 50 mmHg o > 110 mmHg; frecuencia cardíaca < 50 o > 100 latidos por minuto
    11. Resultado más reciente de TFGe desde el IM < 30 ml/min/1,73m2
    12. Disfunción hepática clínicamente relevante
    E.5 End points
    E.5.1Primary end point(s)
    The change in LVEF, EDVI, and ESVI from baseline to 6 months of treatment with 25 mg of BAY 1142524 BID
    Los cambios en la FEVI, el EDVI y el ESVI desde el inicio hasta los 6 meses de tratamiento con 25 mg de BAY 1142524 2 v/d
    E.5.1.1Timepoint(s) of evaluation of this end point
    LVEF, EDVI, and ESVI will be assessed by cardiac MRI (at baseline) during the screening period (5 to 9 days after acute MI) and after 6 months of treatment (visit 4)
    FEVI, el EDVI y el ESVI se evalúan mediante una RM (basal) durante el periodo de selección (5 a 9 días después del infarto agudo de miocardio) y después de 6 meses de tratamiento (visita 4).
    E.5.2Secondary end point(s)
    1. Analysis of the composite of CV mortality and re-hospitalization for heart failure within 6 months of treatment 
    2. CV hospitalization rate within 6 months of treatment 
    3. Analyze the infarct size (% LV mass), and the WMS, by cardiac MRI during the screening period and after 6 months of treatment with BAY 1142524 and placebo. 
    4. PK analysis (see section 9.5.1 of the protocol)
    5. Biomarker analysis (see section 9.5.2 of the protocol)
    1. Análisis del conjunto de la mortalidad por causa cardiovascular y la rehospitalización por insuficiencia cardíaca en los 6 meses de tratamiento
    2. Tasa de hospitalización por causa cardiovascular en los 6 meses de tratamiento
    3. Analizar el tamaño del infarto (% en masa VI) y el índice de motilidad parietal mediante RM cardíaca, durante el periodo de selección y después de 6 meses de tratamiento con BAY 1142524 y placebo.
    4. Análisis Farmacocinética (PK) (véase sección 9.5.1 del protocolo)
    5. Análisis de biomarcadores (véase la sección 9.5.2. del protocolo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to 6 months of treatment
    2. From baseline to 6 months of treatment
    3. At baselines and after 6 months of treatment
    4. See section 9.5.1 of the protocol
    5. See section 9.5.2 of the protocol
    1. Desde el basal a los 6 meses de tratamiento.
    2. Desde el basal a los 6 meses de tratamiento.
    3. En el basal y después de 6 meses de tratamiento
    4. Véase sección 9.5.1 del protocolo
    5. Véase sección 9.5.2 del protocolo
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerancia
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Czech Republic
    Germany
    Israel
    Italy
    Spain
    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
    For each participating EU country, the end of the study according to the EU Clinical Trials Directive will be reached when the last visit of the last subject for all centres in the respective country has occurred.
    As for this study, important data will be collected after LVLS therefore, the end of the study as a whole will be the date when the clean database is available.
    En cada uno de los países de la UE participantes, y de acuerdo con la Directiva Europea de Ensayos Clínicos, el final del estudio tendrá lugar cuando se haya realizado la última visita al último paciente (LPLV) en todos los centros del país respectivo.
    En cuanto a este estudio, se obtendrán datos importantes tras la LPLV, por lo que el final del estudio como conjunto será la fecha en que estará disponible la base de datos limpia.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days9
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-04
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