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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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:2005-002161-36
    Sponsor's Protocol Code Number:PM-C-0024
    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:2005-11-30
    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 number2005-002161-36
    A.3Full title of the trial
    Randomized comparison of a two-month regimen of irbesartan versus enalapril on cardiovascular markers in patients with acute coronary syndrome without ST segment elevation.

    Comparación aleatorizada de un régimen de dos meses de tratamiento con irbesartán frente a enalapril de los maracadores cardiovasculares en pacientes con sídrome coronario agudo sin elevación del segmento ST
    A.3.2Name or abbreviated title of the trial where available
    ARCHIPELAGO
    A.4.1Sponsor's protocol code numberPM-C-0024
    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 SponsorSanofi-Synthelabo Groupe
    B.1.3.4CountryFrance
    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 Information not present in EudraCT
    D.2.1.1.1Trade name irbesartan
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    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 nameirbesartan
    D.3.2Product code SR 47436
    D.3.4Pharmaceutical form 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 INNirbesartan
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeSR 47436
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Enalapril
    D.2.1.1.2Name of the Marketing Authorisation holderWinthrop Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameenalapril
    D.3.2Product code Not Applicable
    D.3.4Pharmaceutical form 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 INNenalapril
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Síndrome coronario agudo
    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
    Valorar si un régimen de 2 meses de irbesartán en pacientes hospitalizados por síndrome coronario agudo sin elevación del segmento ST puede reducir los marcadores inflamatorios (hsCRP) en comparación con enalapril.
    E.2.2Secondary objectives of the trial
    Comparar ambos regímenes sobre varios otros parámetros biológicos que han demostrado su importancia y su valor clínico predictivo (es decir, el BNP, la microalbuminuria, la troponina I , etc) en esta población de pacientes.
    Comparar sobre los parámetros anteriores el efecto de la instauración temprana del tratamiento frente a la instauración del mismo después del alta hospitalaria.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Pacientes (varones o mujeres)

    1) Edad ≥ 18 años de edad
    2) Pacientes hospitalizados con síntomas de isquemia (último episodio dentro de las 48 h previas a la aleatorización) y al menos una de las siguientes características de SCA sin elevación persistente del segmento ST:- Cambios ECG en el segmento ST o la onda T (depresión o elevación transitoria de al menos 1 mm en ST o cambios en la onda T en al menos 2 derivaciones)- Valores positivos de troponina (de acuerdo con el umbral local)
    3) Se deberá haber obtenido el consentimiento informado por escrito firmado
    E.4Principal exclusion criteria
    Criterios de exclusión:

    Relacionados con el paciente:

    1) Mujeres en edad fértil que no están dispuestas o no pueden usar un método anticonceptivo aceptable durante todo el período del estudio y hasta 4 semanas después del mismo Mujeres en edad fértil que usen un método anticonceptivo prohibido (no procede)
    2) Mujeres embarazadas o en período de lactancia
    3) Mujeres con una prueba de embarazo positiva en el momento de la inclusión o antes de la administración del fármaco del estudio
    4) Sujetos incapaces de seguir los procedimientos del protocolo de acuerdo con la investigación
    5) Pacientes con demencia
    6) Pacientes incapaces de volver para las visitas de seguimiento

    Relacionados con la(s) enfermedad(es) concomitante(s)

    7) Elevación persistente del segmento ST en el ECG
    8) Presión arterial sistólica < 100 mmHg
    9) Estenosis bilateral de la arteria renal
    10) Aclaramiento de creatinina £ 30 ml/mn (basado en el valor de creatinina sérica en el momento del ingreso y la fórmula Cockcroft)
    11) Insuficiencia cardíaca congestiva con síntomas consistentes con la clase III o IV de la New York Heart Association (NYHA)
    12) Estenosis aórtica o mitral
    13) Miocardopatía hipertrófica
    14) Enfermedad del tejido conjuntivo con afectación vascular
    15) Haber sido sometido a una angioplastia, cirugía o haber sufrido un traumatismo en los últimos 3 meses
    16) Programación de una coronariografía/angioplastia o su realización antes de la toma de muestras basal
    17) Presencia de una enfermedad que cursa con fiebre (≥ 38°C), infección viral o bacteriana concomitante conocida, enfermedad autoinmune crónica, enfermedad inflamatoria crónica, cáncer confirmado en evolución
    18) Hiperpotasiemia: niveles de potasio en suero > 5,5 mol/l
    19) Esperanza de vida inferior a un año

    Relacionados con el fármaco del estudio/tratamientos concomitantes

    20) Sensibilidad o intolerancia a los ARA II (olmesartán, candesartán, irbesartán, eprosartán, losartán, telmisartán, valsartán y/o cualquier otro ARA II en desarrollo en la actualidad o anteriormente)
    21) Sensibilidad o intolerancia a los IECA (benazepril, captopril, enalapril, lisinopril, trandolapril, ramipril, quinapril, y/o cualquier otro IECA en desarrollo en la actualidad o anteriormente)
    22) Uso crónico de antinflamatorios no esteroideos (AINE). Se permite el uso de ácido acetilsalicílico.
    23) Tratamiento con alopurinol o procainamida
    24) Uso concomitante de diuréticos ahorradores de potasio (por ejemplo, espironolactona, triamtereno o amilorida), preparados de potasio o sustitutos de la sal que contienen potasio.
    25) Tratamiento con litio
    26) Medicamentos inmunosupresores
    27) Administración de cualquier otro fármaco en investigación durante los últimos 30 días antes de la inclusión en el estudio y durante el curso del mismo

    Otros criterios de exclusión

    28) No se incluirán en este estudio prisioneros o sujetos detenidos (encerrados en contra de su voluntad) para tratamiento de una enfermedad psiquiátrica o física (p. ej. una enfermedad infecciosa)
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal de eficacia: Comparación de la variación relativa con respecto a los niveles basales de la hsCRP el día 60 entre los dos grupos de tratamiento
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Double dummy factorial
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 440
    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 Decision2006-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-23
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