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    Summary
    EudraCT Number:2010-022516-39
    Sponsor's Protocol Code Number:SIMBETA
    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:2011-02-01
    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 number2010-022516-39
    A.3Full title of the trial
    Estudio aleatorizado sobre el efecto hemodinámico de la asociación de simvastatina con betabloqueantes no cardioselectivos en pacientes con cirrosis hepática e hipertensión portal clínicamente significativa.
    A.3.2Name or abbreviated title of the trial where available
    SIMBETA
    A.4.1Sponsor's protocol code numberSIMBETA
    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 SponsorInstitut de Recerca HSCSP
    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 ZOCOR 20 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP AND DOHME DE ESPAÑA, 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.3.4Pharmaceutical 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 INNSIMVASTATINA
    D.3.9.1CAS number 79902-63-9
    D.3.9.3Other descriptive nameSIMVASTATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule*
    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
    Se trata de un estudio hemodinámico, para el estudio del efecto en la progresión de hipertensión portal, de la asociación de simvastatina al tratamiento convencional de la profilaxis primaria en pacientes con cirrosis hepática compensada y varices esofágicas de riesgo.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level HLGT
    E.1.2Classification code 10019654
    E.1.2Term Trastornos hepáticos y hepatobiliares
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal consistirá en evaluar si, en pacientes con cirrosis compensada , hipertensión portal mayor de 10mmHg y varices esofágicas de riesgo, la asociación de un vasodilatador hepático selectivo como la simvastatina junto con betabloqueantes no cardioselectivos pueda tener algún efecto hemodinámico a largo plazo.
    E.2.2Secondary objectives of the trial
    1. Desarrollo de complicaciones relacionadas con la hipertensión portal (hemorragia digestiva alta relacionada con la hipertensión portal, Ascitis, Encefalopatía hepática).
    2. Efectos adversos.
    3. Evaluar el efecto sobre el flujo sanguíneo hepático a través del aclaramiento de verde de indocianina.
    4. Evaluar el efecto sobre la hemodinámica sistémica.
    5. Evaluar el efecto sobre la activación de sistemas vasoactivos (ARP, aldosteronemia).6. Evaluar el efecto sobre encefalopatía hepática mínima (mediante test de PHES y frecuencia crítica de parpadeo).
    7. Evaluar el efecto sobre la fibrosis hepática (mediante Fibroscan).
    8. Evolución de la función hepatocelular estimada mediante los scores de Child-Pugh y MELD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    : 1) Cirrosis hepática diagnosticada por biopsia previa o por criterios clínicos, analíticos y ecográficos; 2) GPP >10 mmHg; 3) Presencia de varices esofágicas grandes o varices esofágicas pequeñas con puntos rojos, varices esofágicas de cualquier tamaño y Pugh C, y/o varices gástricas fúndicas de cualquier tamaño, en una gastroscopia reciente (< 1 mes) 4) Ausencia de episodios previos de hemorragia digestiva 5) Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1) Edad <18 y >80 años; 2) episodio de hemorragia por varices, 3) Trombosis en el eje esplenoportal; 4) Hepa- tocarcinoma; 5) Fallo hepático terminal (Escala de Child-Pugh > 13 puntos); Cualquier comorbilidad que conlleve una limitación terapéutica y/o un pronóstico de vida <12 meses; 7) Insuficiencia renal crónica severa (creatinina > 150 g/L); 8) Contraindicación absoluta del tratamiento con estatinas o alergia a la Simvastatina; 9) Administración concomitante de inhibidores potentes de la CYP3A4 (p. ej., itraconazol, ketoconazol, inhibidores de la proteasa del HIV, eritromicina, claritromicina, telitromicina y nefazodona); 10) Tratamiento previo (<1 mes) con simvastatina u otros hipolipemiantes; 11) Episodios previos de rabdomiolisis; 12) contraindicación a tratamiento con betabloqueantes ( EPOC con hiperreactividad bronquial, estenosis aórtica, bloqueo AV, claudicación intermitente, psicosis grave , asma bronquial), 13) Hipersensibilidad a betabloqueantes,14) administración concomitante de inhibidores potentes del citocromo P-450 (quinidina, fluoxetina, paroxetina y propafenona) 15) Hepatitis alcohólica activa; 16) Negativa a participar en el estudio, o afirmar el consentimiento informado; 17) Tratamiento previo con betabloqueantes o nitratos, o tratamientos endoscópicos para las varices o con derivaciones portosistémas; 18) Embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Valorar el efecto de la asociación de betabloqueantes asociados a simvastatina en la progresión a largo plazo de la hipertensión portal clínicamente significativa
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Information not present in EudraCT
    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 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 ensayo clínico se espera que sea en 3 años, cuando se hayan reclutado 70 paciente en total.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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 Decision2011-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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