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    Summary
    EudraCT Number:2011-001278-24
    Sponsor's Protocol Code Number:MEIN/10/Ran-Cad/003
    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:2011-07-19
    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 number2011-001278-24
    A.3Full title of the trial
    EFFICACY OF RANOLAZINE IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD)
    [EFICACIA DE RANOLAZINA EN PACIENTES CON ARTERIOPATÍA CORONARIA (AC)]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY OF RANOLAZINE IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD)
    [EFICACIA DE RANOLAZINA EN PACIENTES CON ARTERIOPATÍA CORONARIA (AC)]
    A.4.1Sponsor's protocol code numberMEIN/10/Ran-Cad/003
    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 SponsorMenarini International Operations Luxembourg SA
    B.1.3.4CountryLuxembourg
    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 supportMenarini International Operations Luxembourg SA
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenarini International Operations Luxembourg SA
    B.5.2Functional name of contact pointStudy Medical Expert (SME)
    B.5.3 Address:
    B.5.3.1Street AddressVia Walter Tobagi, 8
    B.5.3.2Town/ cityPeschiera Borromeo
    B.5.3.3Post code20068
    B.5.3.4CountryItaly
    B.5.4Telephone number003902516555236
    B.5.5Fax number00390251650530
    B.5.6E-maildzava@lusofarmaco.it
    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 Ranexa
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg 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.3.1Product nameRanexa
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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 INNRANOLAZINE
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB10259MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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.IMP: 2
    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 Ranexa
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg SA
    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 nameRanexa
    D.3.4Pharmaceutical form 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 INNRANOLAZINE
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB10259MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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.IMP: 3
    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 Ranexa
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg SA
    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 nameRanexa
    D.3.4Pharmaceutical form 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 INNRANOLAZINE
    D.3.9.1CAS number 95635-55-5
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB10259MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    Angina de esfuerzo en pacientes con Arteriopatía Coronaria
    E.1.1.1Medical condition in easily understood language
    Angina de esfuerzo en pacientes con Arteriopatía Coronaria. Esta enfermedad se origina por una constriccion de los vasos que llevan sangre al musculo cardiaco.
    Angina de esfuerzo en pacientes con Arteriopatía Coronaria. Esta enfermedad se origina por una constriccion de los vasos que llevan sangre al musculo cardiaco.
    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 10014292
    E.1.2Term Effort angina
    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 del estudio será comprobar si la administración de 750 mg de ranolazina dos veces al día es eficaz para aumentar la capacidad de ejercicio (tiempo de ejercicio en la cinta rodante a la concentracion maxima de ranolazina en plasma)
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios serán comprobar si la ranolazina es eficaz para disminuir la frecuencia de la angina de pecho y el consumo semanal de nitroglicerina.
    La evaluación de la seguridad mediante la valoración de los acontecimientos adversos, los hallazgos analíticos y la exploración física se considerará también un objetivo secundario del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Hombres y mujeres (las mujeres en edad de procrear deberán tomar medidas anticonceptivas adecuadas como implantes, inyecciones hormonales, anticonceptivos orales combinados, dispositivos intrauterinos, abstinencia sexual o pareja vasectomizada).
    Edad de los pacientes mayor o igual a 18 años.
    Pacientes diagnosticados de arteriopatía coronaria confirmada mediante angiografía, IM previo, revascularización previa (ICP, CABG) y con angina de pecho provocada por el ejercicio físico y no controlada con tratamiento estándar.
    Depresión del segmento ST mayor o igual a 1mm en ECG de ejercicio.
    Capacidad para realizar la prueba de esfuerzo.
    Capacidad y voluntad para firmar el consentimiento informado y para cumplir con los procedimientos del estudio.
    Consentimiento informado por escrito previo a la inclusión en el estudio.
    Las mujeres en edad fértil o con menos de dos años de menopausia deberán dar negativo en las pruebas de embarazo en orina.

    Criterios de inclusión en la visita 1
    Depresión del segmento ST mayor o igual a 1mm reproducible en dos pruebas de esfuerzo realizadas con una semana de intervalo (con una diferencia en el ejercicio no superior al 20%).
    E.4Principal exclusion criteria
    Angina de pecho en reposo.
    Anomalías en el ECG en reposo (bloqueo de la rama izquierda del haz de His, depresión del segmento ST en reposo mayor o igual a 1mm, taquiarritmia).
    Presencia de factores que impidan una interpretación satisfactoria del ECG (p.ej., depresión del segmento ST en reposo mayor o igual a 1mm en cualquier derivación, bloqueo de la rama izquierda del haz de His, tratamiento con digoxina) o alteraciones de la repolarización y la conducción cardíaca.
    Insuficiencia cardíaca (clase III o IV de la NYHA).
    Hipertensión arterial moderada-grave (TAS>160 mmHg y/o TAD>100 mmHg).
    Hipotensión arterial.
    Síndrome coronario agudo o proceso de revascularización coronaria en los 3 meses anteriores al reclutamiento.
    Mujeres embarazadas o en periodo de lactancia.
    Cualquier anomalía hematológica o bioquímica clínicamente relevante en los análisis de rutina de la visita de selección, a juicio del investigador.
    Patología coexistente grave, incluidas las enfermedades terminales (cáncer, SIDA, etc.).
    Insuficiencia renal definida como aclaramiento de la creatinina< 30 ml/min.
    Disfunción hepática leve, moderada o grave, o insuficiencia hepática definida como: SGOT o SGPT > 3 veces por encima del límite superior normal o bilirrubina total en suero > 1,5 veces por encima del límite superior normal.
    Prolongación del intervalo QT preexistente (incluido el síndrome congénito de QT largo, hipopotasemia no controlada).
    Pacientes en tratamiento con fármacos que provocan prolongación del intervalo QT como antiarrítmicos de clase Ia (p.ej., quinidina) y clase III (p.ej., dofetilida, sotalol, dronedarona) y antipsicóticos (p.ej., tioridazina, ziprasidona).
    Contraindicaciones para la prueba de esfuerzo (p.ej., pericarditis o miocarditis aguda, TVP, estenosis aórtica grave)
    Demencia, psicosis, alcoholismo (>350 g de etanol/semana) o abuso crónico de medicamentos, fármacos o psicofármacos.
    Trastornos que a juicio del investigador puedan interferir en la ejecución del estudio o que aconsejen que el paciente no participe por motivos de seguridad.
    Riesgo de poca colaboración del paciente.
    Incapacidad o falta de voluntad para dar su consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    El cambio en la duración total del ejercicio en la cinta rodante con ranolazina o placebo a niveles máximos de ranolazina en plasma (4 h. después de la administración de la dosis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    tras 24 semanas de tratamiento a dosis completa.
    E.5.2Secondary end point(s)
    - El cambio en la duración total del ejercicio en la cinta rodante con ranolazina o placebo a niveles máximos de ranolazina en plasma (4 h después de la administración de la dosis) tras 4 (Visita 6) y 12 (Visita 7) semanas de tratamiento a dosis completa.
    - El cambio en el tiempo hasta la depresión del segmento ST de 1 mm con niveles máximos de ranolazina en plasma.
    - El cambio en el tiempo hasta el episodio de angina de pecho con niveles máximos de ranolazina en plasma.
    - El número de episodios de angina de pecho por semana.
    - El número de comprimidos sublinguales de nitroglicerina consumidos por semana.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Si no se especifica, será objeto en cada visita cuando se haya evaluado el parámetro correspondiente
    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 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) 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 No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    Ultimo paciente, ultima visita
    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 months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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.1.2.1Number of subjects for this age range: 1440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1440
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state288
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1397
    F.4.2.2In the whole clinical trial 1440
    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)
    El investigador puede decidir como tratar a los pacientes una vez hayan finalizado el estudio. Todos los tratamientos disponibles están permitidos.
    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 Decision2011-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
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