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    Summary
    EudraCT Number:2010-019937-85
    Sponsor's Protocol Code Number:dmestatina
    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:2010-05-24
    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 number2010-019937-85
    A.3Full title of the trial
    Dieta Mediterránea, Ejercicio y Estatinas en el Tratamiento de la Dislipemia
    A.4.1Sponsor's protocol code numberdmestatina
    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 SponsorDr. Luis Serra Majem
    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 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.2.5The 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 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.3.10 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dislipidemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level PT
    E.1.2Classification code 10058108
    E.1.2Term Dislipidemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar qué aportan desde el punto de vista terapéutico la adicción de estatinas a un programa de ejercicio o dieta mediterránea en términos de reducción del riesgo cardiovascular y mejora de los parámetros sistémicos y musculares de inflamación y tolerancia a la insulina, en pacientes con hipercolesterolemia
    E.2.2Secondary objectives of the trial
    1. Deteminar si los efectos beneficiosos del ejercicio y la dieta mediterránea sobre el perfil lipídico y el riesgo cardiovascular son similares y si existe complementariedad aditiva o sinérgica entre ambas intervenciones
    2. Determinar los mecanismos por los que la dieta mediterránea reduce la inflamación sistémica y, por tanto el riesgo cardiovascular
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Varón
    Edad entre 18 y 65 años.
    Hipercolesterolemia (LDL-colesterol > 100 mg/dl o HDL-colesterol < 40 mg/dl)
    Sin contraindicaciones médicas a la realización de ejercicio de intensidad moderada.
    Sin alteraciones del aparato locomotor que puedan limitar la capacidad para realizar ejercicio.
    No haber sido intervenido quirúrgicamente en los tres meses anteriores al inicio del estudio.
    No haber recibido tratamiento hipolipemiante con anterioridad.
    No estar tomando fármacos por enfermedades crónicas al inicio del estudio.
    No fumador (o fumador de menos de 1 paquete día).
    Función hepática normal.
    CPK normales al inicio del estudio.
    Función renal normal.
    Electrocardiograma en reposo normal.
    Prueba de esfuerzo normal
    E.4Principal exclusion criteria
    Ser portador de prótesis de cadera o rodilla.
    Cualquier enfermedad crónica metabólica, reumática o respiratoria.
    Estar sometido a tratamiento médico por cualquier causa.
    Contraindicación médica a la práctica de ejercicio.
    Depresión.
    Insuficiencia cardiaca.
    Tensión arterial > 140-90
    Hipertensión con tratamiento farmacológico
    Diabetes insulina-dependiente.
    Enfermedades neurodegenerativas.
    Accidente cerebrovascular.
    Cojera. Ciática.
    Peso mayor o igual a 110 kg
    Miopatía
    E.5 End points
    E.5.1Primary end point(s)
    Marcadores intermedios de riesgo cardiovascular y cambios en los mismos, consumo máximo de oxígeno (VO2max) y velocidad máxima de oxidación de grasas, parámetros antropométricos, composición corporal con absorciometría fotónica dual de rayos X, biomarcadores de estado nutricional, oxidación, inmunidad e inflamación. En el contexto de este proyecto se llevará a cabo una biopsia muscular del vasto lateral del cuádriceps antes del inicio del tratamiento a los tres y a los seis meses. Las piezas de biopsia serán utilizadas para determinar el tipo de fibras predominantes a través de la identificación de la isoformas de cadena pesada de la miosina mediante electroforesis. Así mismo, se determinarán en músculos esquelético la fosforilación basal de AMPK, STAT3, SOCS3, PTP1B, relacionados con la resistencia a la insulina y a la leptina; la fosforilación basal de JAK2, y la expresión proteica de receptores de leptina, relacionados con la resistencia muscular a la acción de la leptina; la actividad HDA, CS y la expresión de SIRT1 (inducible por resveratrol) y PGC-1alfa;. Así mismo se determinarán componentes esenciales de la cascada de señalización del factor nuclear kappa B (NF-kappa;B).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dieta mediterránea y ejercicio
    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
    Con este diseño experimental esperamos poder explicar por qué mecanismos ejercen efectos beneficiosos la dieta mediterránea, el ejercicio y las estatinas. Los resultados obtenidos permitirán también determinar qué sinergias se producen al combinar dieta y estatinas o estatinas y ejercicio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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) No
    F.2 Gender
    F.2.1Female No
    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 state60
    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 Decision2010-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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