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    Summary
    EudraCT Number:2011-000755-17
    Sponsor's Protocol Code Number:CompHDL2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-10-18
    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 number2011-000755-17
    A.3Full title of the trial
    Effect of nicotinic adic on the composition of high density lipoprotein (HDL) and endothelial function in patients with premature coronary heart disease and elevated HDL-cholesterol.
    Efecto del ácido nicotínico sobre la composición de las lipoproteínas de alta densidad (HDL) y la función del endotelio arterial en los pacientes con cardiopatía isquémica prematura y concentraciones elevadas de colesterol-HDL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of nicotinic adic on the composition of high density lipoprotein (HDL) and endothelial function in patients with premature coronary heart disease and elevated HDL-cholesterol.
    Efecto del ácido nicotínico sobre la composición de las lipoproteínas de alta densidad (HDL) y la función del endotelio arterial en los pacientes con cardiopatía isquémica prematura y concentraciones elevadas de colesterol-HDL.
    A.4.1Sponsor's protocol code numberCompHDL2011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01450410
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorXavier Pintó Sala
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportLaboratorios Merck Sharp & Dohme
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Bellvitge (Unitat de risc vascular)
    B.5.2Functional name of contact pointEmili Corbella
    B.5.3 Address:
    B.5.3.1Street AddressFeixa Llarga s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number932607195
    B.5.5Fax number932607881
    B.5.6E-mailemilic@bellvitgehospital.cat
    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 Tredaptive
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharpe & Dohme Ltd.
    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 nameTredaptive
    D.3.2Product code Tredaptive
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNICOTINIC ACID
    D.3.9.1CAS number 59-67-6
    D.3.9.2Current sponsor codeML/25/1
    D.3.9.4EV Substance CodeSUB09247MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 571170-77-9
    D.3.9.3Other descriptive nameLAROPIPRANT
    D.3.9.4EV Substance CodeSUB26696
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboModified-release tablet
    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
    cardiopatía isquémica prematura y concentraciones elevadas de colesterol-HDL
    E.1.1.1Medical condition in easily understood language
    cardiopatía isquémica prematura y concentraciones elevadas de colesterol-HDL
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008936
    E.1.2Term Chronic ischaemic heart disease, unspecified
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 es comparar las variaciones en el contenido en apolipoproteína A1 de las lipoproteínas de alta densidad (HDL) entre el grupo tratado con ácido nicotínico y el tratado con placebo en los pacientes con cardiopatía isquémica y c-HDL alto.
    E.2.2Secondary objectives of the trial
    -Comparar las diferencias observadas en el cambio en la vasodilatación arterial en situación de hiperemia entre los grupos tratados con ácido nicotínico y con placebo.
    -Comparar las diferencias observadas en el cambio en los componentes lipídicos y proteicos de las lipoproteínas de alta densidad (HDL) entre los grupos tratados con ácido nicotínico y con placebo.
    - Analizar la relación entre las variaciones de la concentración y la composición de las HDL con los cambios en las concentraciones séricas de los restantes parámetros del metabolismo lipídico
    - Evaluar la seguridad del tratamiento con ácido nicotínico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sexo masculino o femenino
    - Edad > 25 años
    - Haber presentado un episodio de cardiopatía isquémica antes de los 55 años en los hombres y de los 65 años en las mujeres
    - Concentración sérica de c-HDL superior al percentil 90 de la población española: >= 2,0 mmol/L en las mujeres y >= 1,8 mmol/L en los hombres (Gómez-Gerique JA, et al. Med.Clin (Barc.). 1999; 113: 730-735.)
    - Tratamiento estable con cualquier estatina en las 6 semanas previas: simvastatina, atorvastatina, rosuvastatina, pravastatina o lovastatina
    - En el caso de mujeres fértiles: prueba de embarazo negativa
    E.4Principal exclusion criteria
    Hipercolesterolemia o hipertrigliceridemia no controladas: c-LDL > 2,6 mmol/L o triglicéridos > 2,24 mmol/L
    - Pacientes con un evento episodio de cardiopatía isquémica en los últimos 3 meses
    - Pacientes afectos de enfermedades inflamatorias agudas o crónicas en los últimos 3 meses
    - Tratamiento con fibratos o ácidos grasos omega-3.
    - Tratamiento con corticoides o fármacos inmunosupresores
    - Pacientes con contraindicación para el tratamiento con tredaptive (Hispersensibilidad a los principios activos o alguno de los excipientes, Disfunción hepática importante o inexplicable, Úlcera péptica activa, sangrado arterial).
    - Pacientes en tratamiento con fármacos que puedan interactuar con tredaptive (Midazolam).
    - Mujer que no está dispuesta a utilizar al menos un método anticonceptivo altamente eficaz durante las 18 semanas del estudio, salvo que sea posmenopáusica o estéril; la menopausia se define como 12 meses seguidos de amenorrea espontánea; los métodos altamente eficaces incluyen píldoras anticonceptivas, inyecciones, implantes o parches, dispositivos intrauterinos (DIU), actividad sexual con un hombre que se haya sometido a una vasectomía, preservativos o dispositivos oclusivos (diafragma o capuchón cervical/en bóveda) utilizado con espermicida.
    - Mujer embarazada o en período de lactancia, o que planee quedarse embarazada durante las 18 semanas del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    cambios en la concentración de la apolipoproteína A1 de las HDL, entre el inicio y la semana 12 de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Semana 12
    E.5.2Secondary end point(s)
    Las variables secundarias serán los cambios en la vasodilatación dependiente del endotelio y las variaciones en la concentración de los componentes de la HDL: colesterol, triglicéridos, fosfolípidos, apolipoproteínas A2, E, J y F, amiloide A, paraoxonasa, fosfolipasa A2, clorotirosina, nitrotirosina y LCAT mediante ambos tratamientos. También se incluirán como variables secundarias los cambios en las concentraciones séricas de colesterol, triglicéridos, c-LDL y c-No HDL, apolipoproteínas A1 y B, glucosa, HbA1c y ácido úrico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 semanas
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 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.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    Última visita (seguridad) del último paciente incluido en el estudio.
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    (figura en el protocolo)
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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