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    Summary
    EudraCT Number:2011-004507-20
    Sponsor's Protocol Code Number:MEIN/11/RAN-HCM/001
    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:2011-10-13
    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 number2011-004507-20
    A.3Full title of the trial
    RANOLAZINE IN PATIENTS WITH SYMPTOMATIC
    HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY
    ASSESSING THE EFFECTS ON EXERCISE CAPACITY,
    DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS
    RANOLAZINA EN PACIENTES CON MIOCARDIOPATÍA HIPERTRÓFICA SINTOMÁTICA: ESTUDIO PILOTO PARA EVALUAR LOS EFECTOS SOBRE LA CAPACIDAD DE ESFUERZO, LA FUNCIÓN DIASTÓLICA Y EL ESTADO SINTOMÁTICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SHMC
    Estudio para evaluar los efectos de ranolazina en pacientes con miocardiopatía hipertrófica sintomática.
    A.4.1Sponsor's protocol code numberMEIN/11/RAN-HCM/001
    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 S.A.
    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 organisationA. Menarini Farmaceutica Internazionale s.r.l.
    B.5.2Functional name of contact pointDonatella Bemporad, MD
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code1 50131
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 055 5680685
    B.5.5Fax number+39 055 5680484
    B.5.6E-mailDBemporad@menarini.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 AuthorisationEuropean Union
    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 Ranolazine 500 mg PR tablets
    D.3.4Pharmaceutical form Film-coated 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 codeRanolazine PR
    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.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 S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRanolazine 750 mg PR tablets
    D.3.4Pharmaceutical form Film-coated 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 codeRanolazine PR
    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: 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 AuthorisationArmenia
    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 nameRanolazine 1000 mg PR tablets
    D.3.4Pharmaceutical form Film-coated 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 codeRanolazine PR
    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 number1000
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated 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
    symptomatic hypertrophic cardiomyopathy (SHCM)
    Cardiomiopatía sintomática hipertrófica
    E.1.1.1Medical condition in easily understood language
    heart disease
    Enfermedad cardiaca
    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 PT
    E.1.2Classification code 10020871
    E.1.2Term Hypertrophic cardiomyopathy
    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
    The primary study objective will be to demonstrate the efficacy of ranolazine in improving the Exercise capacity in patients affected by SHCM using the V02 peak technique
    El objetivo principal de este estudio será demostrar la eficacia de ranolazina en la mejoría de la capacidad de esfuerzo en pacientes afectados por MCHS utilizando la técnica del VO2 máximo.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be to demonstrate the efficacy of ranolazine on diastolic function, symptomatic status and natriuretic peptide biomarker proBNP in patients affected by SHCM. The assessment of safety by evaluation of adverse events, laboratory findings, the rest standard 12-lead ECG, detection of 24-hour arrhythmic burden by Holter ECG monitoring and physical examination will also be considered a secondary study objectives.
    Los objetivos secundarios serán demostrar la eficacia de ranolazina en la función diastólica, el estado sintomático y el biomarcador péptido natriurético proBNP en pacientes con MCHS. La evaluación de la seguridad mediante la valoración de los acontecimientos adversos, los resultados analíticos, el ECG de 12 derivaciones estándar en reposo, la detección de la carga arrítmica en 24 horas mediante registro ECG Holter y la exploración física también se considerarán objetivos secundarios del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Male and female gender;
    ? Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
    ? Patients which fulfil conventional echocardiographic criteria for the diagnosis of SHCM: Maximum LV wall thickness >= 1.5 cm;
    ? Patients aged > 18 years;
    ? Patients with exertion symptoms and functional limitation (angina and or HF NYHA II-III);
    ? Presence of sinus rhythm;
    ? Peak V02 < 75% of predicted for age and gender;
    ? Absence of resting LV outflow tract obstruction (peak gradient < 30 mmHg);
    ? Written informed consent prior to enrolment into the study.
    ? Pacientes de ambos sexos;
    ? Las mujeres en edad fértil o en los dos años siguientes de la menopausia deben tener un resultado negativo en la prueba de embarazo en orina (las mujeres en edad fértil deben estar usando métodos anticonceptivos eficaces, como implantes, anticonceptivos inyectables u orales combinados, dispositivos intrauterinos, abstinencia sexual o pareja con vasectomía);
    ? Pacientes que cumplan los criterios ecocardiográficos convencionales para el diagnóstico de MCHS: Grosor parietal máximo del VI ? 1,5 cm;
    ? Pacientes > 18 años de edad;
    ? Pacientes con síntomas y limitación funcional durante la prueba de esfuerzo (angina o IC grado II-III de la NYHA)
    ? Presencia de ritmo sinusal;
    ? VO2 máximo < 75% del valor predicho para la edad y sexo;
    ? Ausencia de obstrucción en el tracto de salida del VI en reposo (gradiente máximo < 30 mmHg);
    ? Consentimiento informado por escrito antes de la inclusión en el estudio.
    E.4Principal exclusion criteria
    ? Females of childbearing potential not using adequate contraceptive precautions;
    ? Females who are pregnant or lactating;
    ? Presence of known coronary artery disease (CAD);
    ? Presence of Chronic Obstructive Airways Disease;
    ? Concomitant administration of potent CYP3A4 inhibitors
    ? Concomitant administration of dronedarone Class Ia (e.g. quinidine) or Class III (e.g. sotalol) antiarrhythmics other than amiodarone, or other QT-prolonging drugs;
    ? Patients with QTc at baseline >= 500 ms;
    ? Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator?s judgment;
    ? Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.);
    ? Severe renal impairment defined as GFR < 29 mL/min; creatinine level > 2.5 mg/dL; BUN >60 mg/dL;
    ? Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper
    limit;
    ? Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or
    psychoactive substances;
    ? Conditions which in the Investigator?s opinion may interfere with the study?s execution or due to which the patient should not participate for safety reasons;
    ? Risk of low patient cooperation;
    ? Inability or unwillingness to issue the informed consent;
    ? Inability to perform a cardiopulmonary test;
    ? Lactose intolerance.
    ? Mujeres en edad fértil que no estén utilizando métodos anticonceptivos adecuados;
    ? Mujeres embarazadas o lactantes;
    ? Diagnóstico de arteriopatía coronaria (AC)
    ? Presencia de enfermedad pulmonar obstructiva crónica;
    ? Administración concomitante de inhibidores potentes de la enzima CYP3A4 (p. ej., itraconazol, ketoconazol, voriconazol, posaconazol, inhibidores de la proteasa del VIH, claritromicina, telitromicina y nefazodona);
    ? Uso concomitante de dronedarona, antiarrítmicos del grupo Ia (p. ej., quinidina) o del grupo III (p. ej., dofetilida o sotalol), aparte de amiodarona, u otros fármacos que prolonguen el intervalo QTc;
    ? Pacientes con QTc ? 500 ms en el momento basal;
    ? Cualquier anomalía hematológica o bioquímica clínicamente relevante en el despistaje rutinario, según el criterio del investigador;
    ? Patología concurrente grave, incluida enfermedad terminal (cáncer, SIDA, etc.);
    ? Insuficiencia renal grave, definida como un índice de filtración glomerular < 29 ml/min; creatinina sérica > 2,5 mg/dl; urea > 60 mg/dl;
    ? Deterioro hepático moderado o grave o insuficiencia hepática definida por una SGOT o SGPT > 2 veces el límite superior de la normalidad o bilirrubina sérica total > 1,5 veces el límite superior de la normalidad;
    ? Demencia, psicosis, alcoholismo (> 350 g etanol/semana) o abuso crónico de medicamentos, drogas o sustancias psicoactivas;
    ? Afecciones que, en opinión del investigador, pudieran interferir con la ejecución del estudio o debido a las cuales el paciente no debería participar por motivos de seguridad;
    ? Riesgo de escasa colaboración por parte del paciente;
    ? Incapacidad o falta de disposición para otorgar su consentimiento informado;
    ? Incapacidad de realizar el estudio cardiopulmonar.
    ? Intolerancia a la lactosa
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of Exercise Capacity with the V02 peak in patients with SHCM after 5 months of treatment with ranolazine or placebo
    Evaluación del VO2 máximo con la prueba cardiorrespiratoria, después de 5 meses recibiendo la dosis máxima alcanzada de ranolazina o placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 5 months
    Tras 5 meses
    E.5.2Secondary end point(s)
    E/E? ratio evaluation; Natriuretic peptides biomarkers evaluation (proBNP biomarkers); Symptomatic Status evaluation (Minnesota Living With Heart Failure Questionnaire)
    ? Evaluación del cociente E/E? con la técnica DT
    ? Evaluación del biomarcador péptido natriurético mediante el proBNP
    ? Evaluación del estado sintomático con el cuestionario MLWHFQ (Minnesota Living With Heart Failure Questionnaire).
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 1 and 5 months
    Tras 1 y 5 meses
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    LPLV
    último visita del último paciente
    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 months11
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days14
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    normal treatment
    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 Decision2012-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-14
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