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    Summary
    EudraCT Number:2009-012269-71
    Sponsor's Protocol Code Number:BC22140
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2009-12-15
    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 number2009-012269-71
    A.3Full title of the trial
    Estudio de eventos cardiovasculares para evaluar el potencial de aleglitazar en la reducción del riesgo cardiovascular en pacientes con un episodio reciente de síndrome coronario agudo (SCA) y diabetes mellitus tipo 2 (DM2).

    Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D).
    A.4.1Sponsor's protocol code numberBC22140
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAleglitazar
    D.3.2Product code RO0728804
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAleglitazar
    D.3.9.2Current sponsor codeRO0728804
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Pacientes con diabetes tipo 2 con un episodio reciente de síndrome coronario agudo (SCA).

    Type 2 diabetes patients with a recent acute coronary syndrome (ACS) event.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10007649
    E.1.2Term Cardiovascular disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si aleglitazar reduce la mortalidad y morbilidad cardiovascular (definida como infarto de miocardio no fatal (IM) y accidente cerebrovascular no fatal) en pacientes con un episodio reciente de SCA y DM2.
    E.2.2Secondary objectives of the trial
    • Evaluar los efectos de aleglitazar en otras variables clínicas de riesgo cardiovascular
    • Evaluar los efectos de aleglitazar en el control glucémico, el perfil de lipoproteínas, la presión arterial y los biomarcadores de riesgo cardiovascular
    • Evaluar la tolerabilidad y el perfil de seguridad a largo plazo de aleglitazar (con especial atención los acontecimientos adversos conocidos de la clase PPAR como retención de líquidos, insuficiencia cardíaca, fracturas, función renal, acontecimientos adversos músculo-esqueléticos y elevación de las enzimas hepáticas)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1) Subestudio de PK: Farmacocinética y Farmacodinámica; Incluido en el protocolo . Objetivos: Las muestras de sangre para la medición de las concentraciones plasmáticas de aleglitazar.
    2) RCR (Roche Clinical Repository)
    Incluido en el protocolo principal; Objetivo:Las muestras RCR se recogerán con fines de investigación para ayudar a comprender mejor la respuesta del paciente al tratamiento con aleglitazar además de la patogénesis y el curso de la diabetes, el SCA y las enfermedades relacionad
    E.3Principal inclusion criteria
    1. Hombres o mujeres > 18 años de edad
    2. DM2 conocida o DM2 recién diagnosticada (confirmado antes de la aleatorización según los criterios de la Asociación Americana de Diabetes, véase Apartado 4.4 del protocolo)
    3. Hospitalización por un episodio de SCA (véase la definición más abajo) y aleatorización en un plazo de 2 a 6 semanas después del evento índice de SCA (día de la hospitalización). En caso de cualquier episodio de SCA, IM relacionado con el procedimiento o cirugía coronaria de revascularización miocárdica posteriores, que ocurran durante el periodo run-in, la aleatorización debería tener lugar entre 2 y 6 semanas a partir de este episodio. En estos pacientes, la duración máxima permitida desde el evento índice hasta la aleatorización es de 12 semanas.
    4. Capacidad y disposición para otorgar el consentimiento informado por escrito y para cumplir con los requisitos del estudio.
    E.4Principal exclusion criteria
    1. Tratamiento concomitante con tiazolidinediona y/o fibrato
    2. Intolerancia previa a una tiazolidinediona y/o fibrato
    3. Triglicéridos (en ayunas) > 400 mg/dL (> 4.5 mmol/L)
    4. Pacientes con enfermedad hepática clínicamente manifiesta, por ejemplo, ictericia, coleastasis, deterioro de la función hepática, hepatitis activa o ALT > 3 x LSN asintomática
    5. Anemia definida como hemoglobina < 10 g/dL (< 100 g/L, 6.21 mmol/L) o hematocrito < 30 %
    6. TFGcMDRD < 45 ml/min/1.73m2
    7. Insuficiencia cardíaca congestiva sintomática clasificada como clase II-IV de la NYHA en el momento de la aleatorización
    8. Hospitalización en el periodo de 12 meses precedente al evento índice, por un diagnóstico primario de insuficiencia cardíaca
    9. Edema periférico que, a juicio del investigador, se considere que es clínicamente severo
    10. Terapia con corticosteroides sistémicos durante > 2 semanas, dentro de los 3 meses previos a la visita de selección
    11. Cualquier condición médica grave que, a juicio del investigador, pudiese interferir en la realización del estudio
    12. Enfermedad comórbida grave en que la esperanza de vida del paciente sea inferior a la duración del ensayo (por ejemplo, infección sistémica aguda, cáncer u otras enfermedades graves). El carcinoma de células basales tratado que ocurra > 2 años antes de la aleatorización no está excluido
    13. No disposición o incapacidad para cumplir con los requisitos del estudio (incluyendo sujetos cuya cooperación sea dudosa debido a abuso de drogas o a dependencia del alcohol)
    14. Prueba de embarazo positiva, mujeres en periodo de lactancia o mujeres en edad fértil que no utilicen un método anticonceptivo altamente eficaz.
    15. Participación en cualquier ensayo clínico con un fármaco o dispositivo en investigación durante el mes previo a la selección
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de este estudio es el tiempo transcurrido hasta la primera incidencia de cualquier componente de la variable compuesta, adjudicado por el Comité de Eventos Clínicos. Los componentes de la variable principal son muerte cardiovascular, infarto de miocardio no fatal y accidente cerebrovascular no fatal.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned29
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio se define como la fecha de la última visita del último paciente, o la fecha en la que se reciba el último dato necesario para el análisis estadístico (es decir, resultados de seguridad y de eficacia principales para tomar la decisión), lo que ocurra más tarde.
    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 months3
    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 months3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 6000
    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 Decision2010-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-15
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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