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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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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:2008-001192-29
    Sponsor's Protocol Code Number:cv-08/025
    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:2008-05-12
    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 number2008-001192-29
    A.3Full title of the trial
    “Evaluación mediante proteómica de biomarcadores proteicos asociados con el tratamiento con Eplerenona versus espironolactona en pacientes post-infarto agudo de miocardio, diabéticos con hipertensión arterial no controlada y disfunción ventricular sistólica leve”
    "Identification of proteomic biomarkers associated with eplerenone treatment versus spironolactone in post-acute coronary syndrome patients, with non-controlled arterial hypertension and ventricular dysfunction"
    A.3.2Name or abbreviated title of the trial where available
    PROMETEO
    A.4.1Sponsor's protocol code numbercv-08/025
    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 SponsorFundación Investigación y Desarrollo en el Area Cardiovascular
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name INSPRA (eplerenona)
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameINSPRA (eplerenona)
    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 INNEPLERENONE
    D.3.9.1CAS number 107724-20-9
    D.3.9.3Other descriptive nameINSPRA, EPLERENONA, EPLERENONUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 ALDACTONE (espironolactona)
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameALDACTONE
    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 INNspironolactone
    D.3.9.1CAS number 52017
    D.3.9.3Other descriptive nameALDACTONE A, ESPIRONOLACTONA, SPIRONOLACTONE, SPIRONOLACTON
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Disfunción ventricular leve-moderada post-infarto agudo de miocardio en pacientes diabéticos con hipertensión arterial no controlada.

    Low-moderate ventricular dysfunction in post-acute coronary syndrome patients with diabetes and non-controlled arterial hypertension.
    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
    -Analizar mediante proteómica si la expresión de diferentes biomarcadores asociados con daño vascular y miocárdico, incluyendo fibrosis, inflamación y estrés oxidativo, pueden ser diferentes en el plasma y leucocitos obtenidos de pacientes tratados bien con eplerenona o con espironolactona.
    -Comparar los cambios moleculares observados tras el tratamiento con eplerenona y espironolactona.
    E.2.2Secondary objectives of the trial
    -Determinar en pacientes diabéticos con hipertensión arterial no controlada post-infarto agudo de miocardio y disfunción ventricular leve, si el tratamiento con eplerenona mejora en mayor medida la evolución clínica de los pacientes en comparación con los tratados con espironolactona.
    -Analizar si el número de receptores de aldosterona y/o niveles circulantes de aldosterona pueden asociarse con una mayor o menor respuesta a los diferentes tratamientos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) edad > 18 años, sin límite superior de edad
    2) Pacientes con diabetes mellitus tanto tipo I como tipo II.
    3) Pacientes con hipertensión arterial no controlada. Se entiende por hipertensión arterial no contralada en el paciente diabético aquella definida por valores de presión sistólica mayor o igual 125 mmHg y diastólica mayor o igual a 75 mmHg, a pesar del tratamiento con IECAS/ARAII más beta-bloqueantes.
    4) Pacientes que hayan sufrido recientemente un infarto agudo de miocardio con o sin elevación del segmento ST (menos de 5 días antes)
    3) Pacientes con disfunción sistólica leve con una fracción de eyección entre 40-55%.
    4) K+ ≤ 5 mmol/l
    5) Aclaramiento de creatinina > 35 (según la fórmula de Cockcroft):
    (140-edad) x peso (kg)
    Creatinina plasmática (mg/dl) x 72
    * Se multiplica por 0.85 únicamente en el caso de las mujeres
    6) HbA1c ≤ 10% y mayor o igual a 6% en el momento de inclusión en el estudio
    7) AST/ALT/gamma GT < límite superior x 3 en el momento de inclusión en el estudio
    8) Todos los pacientes deben recibir independientemente del fármaco asignado en el estudio la siguiente medicación, salvo intolerancia:
    a.-Antiagregación plaquetaria (en caso de alergia documentada a la aspirina, el paciente deberá recibir una tienopiridina)
    b.-IECAS/ARA II
    c.-beta-bloqueantes
    d.-Estatinas
    E.4Principal exclusion criteria
    1) Sujetos con K+ >5 mmol/l
    2) Aclaramiento de creatinina < 35 (según la fórmula de Cockcroft).
    3) FEVI < 40% y >55%
    4) Mujeres en edad fértil y sin tratamiento anticonceptivo oral
    5) Mujeres en estado de gestación
    6) Pacientes con enfermedad inflamatoria crónica o tumoral
    7) Hipertensión arterial no controlada, definida como presión sistólica > 180 mmgHg o presión sistólica > 110 mmHg en los tres meses anteriores a la inclusión en el estudio.
    8) Pacientes que tengan planificada una intervención quirúrgica mayor durante el periodo que dure el estudio.
    9) Alteraciones en la funcionalidad hepática con niveles de transaminasas > 3.
    10) Hepatitis B, C o HIV positivos.
    11) Pacientes que sufran desórdenes psicosociales.
    12) Historia de abuso de tóxicos en los últimos 5 años.
    13) Pacientes que no hayan firmado el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    En el presente estudio nos centraremos en el estudio de la expresión de diferentes proteínas e isoformas de proteínas plasmáticas como son la alfa 1 antitripsina, cadena gamma de fibrinógeno, cadena beta de fibrinógeno, apolipoproteína AIV, apolipoproteína AI, haptoglobina, proteina de unión a vitamina D, ceruloplasmina, etc..
    También se determinarán los niveles plasmáticos de aldosterona y de sus receptores, así como los niveles de potasio, sodio creatinina, glucosa, transaminasas, hemoglobina glicosilada, MMP-1 y 9, TIMP-1, TGF-beta y CD40L.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Information not present in EudraCT
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Yes
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 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 state24
    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 Decision2008-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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