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    Summary
    EudraCT Number:2005-004876-19
    Sponsor's Protocol Code Number:01-05-TL-475-021
    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:2006-01-23
    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 number2005-004876-19
    A.3Full title of the trial
    Estudio randomizado y doble ciego para evaluar la eficacia y seguridad de TAK-475 100 mg o placebo cuando se administra conjuntamente con una terapia de dosis alta de estatina en sujetos con Hipercolesterolemia Primaria
    A.4.1Sponsor's protocol code number01-05-TL-475-021
    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 SponsorTakeda Europe R&D Centre Ltd
    B.1.3.4CountryUnited Kingdom
    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.2.5The 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.3.2Product code TAK-475
    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.3.9.2Current sponsor codeTAK-475
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeSmall molecule squalene synthase inhibitor
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tratamiento de pacientes con hipercolesterolemia primaria que están en tratamiento con atorvastatina (80 mg), simvastatina (80 mg) o rosuvastatina (40 mg)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8
    E.1.2Level PT
    E.1.2Classification code 10058108
    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 primario es evaluar el cambio del colesterol de lipoproteína de baja densidad (C-LDL) en sujetos con hipercolesterolemia primaria tratados con TAK-475 100 mg QD o placebo QD cuando se administra conjuntamente con una dosis alta de atorvastatina, rosuvastatina o simvastatina después de 24 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son para evaluar:
    - la seguridad y tolerabilidad (acontecimientos adversos [AA], pruebas de laboratorio de seguridad, examen físico [EF], constantes vitales, mejor agudeza visual corregida [MAVC] y electrocardiograma [ECG]).

    - los cambios en las variables de lípidos secundarios (colesterol total [CT], colesterol de lipoproteína de alta densidad [C-HDL], triglicéridos [TG], colesterol de lipoproteína de muy baja densidad [C-VLDL], apolipoproteína A1 [Apo A1], apolipoproteína B [Apo B] y variables de lípidos derivadas).

    - el cambio en la proteína C-reactiva de alta sensibilidad (hs-CRP).

    - el porcentaje de sujetos que alcanzan concentraciones de C-LDL de <130, <100 y <70 mg/dl en la visita final.

    - la seguridad a largo plazo del tratamiento con TAK-475 en esta población durante el período de extensión a etiqueta abierta.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Sujetos adultos, varones o mujeres (no embarazadas ni en periodo de lactancia) de por lo menos 18 años de edad, que cumplan con los siguientes criterios en cuanto a los lípidos:

    - Antes de la Aleatorización, el sujeto debe tener un promedio de C-LDL ³100 mg/dl (2,59 mmol/l) en 2 muestras consecutivas (tomadas por lo menos con 1 semana de diferencia). La diferencia entre los dos valores individuales de C-LDL no debe exceder el 15% del valor superior.

    - Antes de la Aleatorización, el sujeto debe tener un promedio de triglicéridos £400 mg/dl (4,52 mmol/l) en 2 muestras consecutivas (tomadas por lo menos con 1 semana de diferencia). El valor superior para cualquiera de las muestras debe ser £450 mg/dl (5,1 mmol/l).

    El sujeto debe estar tomando la dosis recomendada más alta de un inhibidor de la HMG-CoA reductasa una vez al día durante por lo menos 4 semanas antes de la visita 1. Los sujetos que se encuentren bajo régimen estable de ezetimiba, además de su inhibidor de la HMG-CoA reductasa podrán participar del estudio y continuar con ezetimiba.
    E.4Principal exclusion criteria
    Los sujetos que cumplan cualquiera de estos criterios no reunirán las condiciones para entrar en el estudio:

    - una mujer embarazada, en período de lactancia, que pretende quedar embarazada durante el estudio o no desea usar métodos anticonceptivos aceptables durante el estudio;

    - si tienen niveles elevados de alanina-aminotransferasa (ALT) o aspartato-aminotransferasa (AST) (>1,5 veces el límite normal superior [LNS]), enfermedad hepática activa, ictericia o antecedentes de enfermedad hepática;· si tiene nivel de creatinina sérica >135 mmol/l (1,5 mg/dl);

    - si tiene nivel elevado de creatina-fosfoquinasa (>3 veces LNS);· si tiene diabetes, con un nivel de HbA1c >8% en la visita 1;

    - si tiene antecedentes de infarto de miocardio, angina inestable, ataques isquémicos transitorios, accidentes cerebrovasculares, intervención coronaria percutánea, cirugía arterial coronaria o periférica (cirugía de injerto de derivación) en los últimos 6 meses antes de la visita 1;

    - si tiene fibromialgia, miopatía, rabdomiólisis o dolor muscular sin explicación;

    - si tiene una hipersensibilidad conocida o antecedentes de reacciones adversas a la atorvastatina, rosuvastatina o simvastatina;

    - si tiene enfermedad intestinal inflamatoria o cualquier otro síndrome de malabsorción o ha tenido derivaciones gástricas u otro procedimiento quirúrgico para la pérdida de peso;

    - si tiene hipertensión no controlada a pesar del tratamiento médico (definido como tensión arterial diastólica en reposo promedio >100 mmHg o tensión arterial sistólica en reposo promedio >160 mmHg) en la visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia primaria es C-LDL directo en ayunas
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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.8.5The 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 2006-01-23. 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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 600
    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 Decision2006-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-06
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