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    Summary
    EudraCT Number:2011-004507-20
    Sponsor's Protocol Code Number:MEIN/11/RAN-HCM/001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-08
    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 ConcernedItaly - Italian Medicines Agency
    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 IN PAZIENTI AFFETTI DA CARDIOMIOPATIA IPERTROFICA SINTOMATICA: STUDIO PILOTA PER VALUTARE GLI EFFETTI SULLA CAPACITA`™ DI ESERCIZIO FISICO, SULLA FUNZIONALITA`™ DIASTOLICA E SULLO STATO SINTOMATICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SHMC
    CARDIOMIOPATIA IPERTROFICA SINTOMATICA
    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 Lexembourg 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 Lexembourg SA
    B.5.2Functional name of contact pointDonatella Bemporad
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi, 3
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number0555680685
    B.5.5Fax number0555680484
    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*60CPR 500MG R.P.
    D.2.1.1.2Name of the Marketing Authorisation holderA.MENARINI IND.FARM.RIUN.Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 codeRanolazione PR
    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.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*60CPR 750MG R.P.
    D.2.1.1.2Name of the Marketing Authorisation holderA.MENARINI IND.FARM.RIUN.Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 codeRanolazione PR
    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: 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.3.4Pharmaceutical 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 codeRanolazione PR
    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 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)
    cardiomiopatia sintomatica ipertrofica
    E.1.1.1Medical condition in easily understood language
    heart disease
    malattia 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 14.1
    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
    dimostrare l`efficacia e la sicurezza di Ranolazina nel migliorare la capacita' di esercizio, la funzione diastolica e lo stato sintomatico nei pazienti affetti da Cardiomiopatia Ipertrofica Sintomatica
    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
    Dimostrare l'efficacia di Ranolazina sulla funzione diastolica, lo stato sintomatico e il peptide biomarcatore natriuretico proBNP in pazienti affetti da Cardiomiopatia Ipertrofica Sintomatica. La valutazione della sicurezza mediante gli eventi avversi, i risultati di laboratorio, ECG standard 12 derivazioni a riposo, rilevazione per 24-ore delle aritmie tramite monitoraggio con Holter ECG e l'esame fisico saranno considerati obiettivi secondari dello studio.
    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; Persons capable to understand the nature, significance and implications of the clinical trial.
    • Uomini e donne; • Le donne in eta' fertile o entro due anni dalla menopausa devono avere un test di gravidanza urinario negativo (le donne in eta' fertile devono utilizzare adeguate precauzioni contraccettive, come impianti, iniettabili, contraccettivi orali combinati, dispositivi intrauterini, astinenza sessuale o partner vasectomizzato); • Pazienti che soddisfano i criteri ecocardiografici convenzionali per la diagnosi di Cardiomiopatia Ipertrofica Sintomatica: pareti del ventricolo sinistro con spessore massimo ≥ 1.5 cm; • Pazienti con eta' &gt; 18 anni; • Pazienti con sintomi da sforzo e limitazione funzionale (angina e/o insufficienza cardiaca di classe II-III NYHA); • Presenza di ritmo sinusale; • Picco V02 &lt; 75% rispetto a quanto atteso in base a eta' e sesso; • Assenza a riposo di ostruzioni al flusso del ventricolo sinistro (gradiente del picco &lt; 30 mmHg ) • Consenso informato scritto prima di essere arruolato nello studio; •Persone capaci di capire la natura, il significato e le implicazioni dello studio clinico.
    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. dofetilide, sotalol) antiarrhythmics other than amiodarone, or other QT-prolonging drugs; Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John‟s Wort) • 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; GFR must always be calculated; • 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 (>280 g ethanol/week for male or >140 g ethanol/week for female patients) 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; Hypersensitivity to ranolazine or one of the excipients.
    • Donne in eta' fertile che non usano adeguate precauzioni contraccettive; • Donne che sono incinte o che stanno allattando; • Presenza di Coronaropatie conosciute; • Presenza di Broncopneumopatia cronica ostruttiva; • Terapia concomitante con potenti inibitori del CYP3A4 (es. itraconazolo, ketoconazolo, voriconazolo, posaconazolo, inibitori proteasici dell’HIV, claritromicina, telitromicina, nefazodone) • Terapia concomitante con Dronedarone, antiaritmici, escluso amiodarone, di Classe Ia (e.g. quinidina) o Classe III (e.g. sotalolo), o altri farmaci che prolungano il tempo di QT; •Uso concomitante di induttori del CYP3A4 (es. rifampicina, fenitoina, fenobarbital, carbamazepina, St. John’s Wort) • Pazienti con QTc basale ≥ 500 ms; • Ogni anormalita' ematologica o biochimica che a giudizio dello sperimentatore sia clinicamente rilevante; • Gravi patologie concomitanti, incluse malattie terminali (neoplasie, AIDS, ecc.); • Insufficienza renale grave definita come GFR &lt; 29 mL/min o creatinina &gt; 2.5 mg/dL; il valore di GFR deve sempre essere calcolato; • Squilibrio epatico moderato o grave o insufficienza epatica definita come livelli di SGOT o SGPT &gt; 2 volte del limite massimo di normalita' o livelli di bilirubina serica totale &gt; 1.5 volte rispetto al limite massimo di normalita'; • Demenza, psicosi, alcolismo (consumo di &gt;280 g di etanolo alla settimana per i pazienti maschi o &gt;140 g di etanolo alla settimana per le pazienti femmine) o abuso cronico di farmaci, droghe o sostanze psicoattive; • Condizioni che a giudizio dello sperimentatore possono interferire con l’esecuzione dello studio o a causa delle quali il paziente non possa partecipare allo studio per motivi di sicurezza; • Rischio di bassa cooperazione da parte del paziente; • Incapacita' o non volonta' di rilasciare il consenso informato; • Inabilita' ad effettuare il test cardiopolmonare; • Intolleranza al lattosio; •Ipersensibilita' alla ranolazina o ad uno degli eccipienti
    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
    Valutazione della capacita' di esercizio fisico in pazienti affetti da Cardiomiopatia Ipertrofica Sintomatica usando la tecnica del picco di consumo di ossigeno (picco V02) dopo 5 mesi di trattamento con Ranolazina o Placebo al massimo dosaggio raggiunto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 5 months
    dopo 5 mesi
    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)
    - Valutazione dei cambiamenti dovuti al trattamento nel rapporto E/E’ usando la tecnica del Doppler Tissutale; - Valutazione del proBNP; - Valutazione dello stato sintomatico usando il Minnesota Living With Heart Failure Questionnaire (MLWHFQ); - Valutazione della sicurezza tramite: o Esame fisico completo; o Test di laboratorio; o 12-lead ECG; o Rilevazione per 24-ore delle aritmie tramite monitoraggio con Holter ECG; o Raccolta degli eventi avversi nella popolazione in studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 1 and 5 months
    dopo 1 e 5 mesi
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned5
    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
    LPLV
    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 months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1Number of subjects for this age range: 0
    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 state40
    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
    trattamento normale
    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 Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-11-14
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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