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    Summary
    EudraCT Number:2012-001355-38
    Sponsor's Protocol Code Number:AP-24534-12-301
    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:2012-09-21
    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 number2012-001355-38
    A.3Full title of the trial
    A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
    Studio di Fase III, Randomizzato, in Aperto, con Ponatinib verso Imatinib in Pazienti adulti con Leucemia Mieloide Cronica in Fase Cronica di nuova diagnosi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    advanced phase study, randomised, open with ponatinib versus imatinib in patients with Chronic Mieloyd Leukemia newly diagnosed
    studio di fase avanzata con trattamento scelto su base casuale, aperto, con ponatinib in confronto a imatinib, in pazienti affetti da Leucemia Mieloide cronica in fase cronica di nuova diagnosi
    A.3.2Name or abbreviated title of the trial where available
    EPIC
    EPIC
    A.4.1Sponsor's protocol code numberAP-24534-12-301
    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 SponsorARIAD PHARMACEUTICALS,INC.
    B.1.3.4CountryUnited States
    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 supportAriad Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmanet Services GmbH Filiale Italiana
    B.5.2Functional name of contact pointClinical Monitoring
    B.5.3 Address:
    B.5.3.1Street AddressVia Maurizio Gonzaga 7
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20123
    B.5.3.4CountryItaly
    B.5.4Telephone number02 8905 3711
    B.5.5Fax number02 8905 3730
    B.5.6E-maildmarchesini@pharmanet-i3.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberC (2010) 789
    D.3 Description of the IMP
    D.3.1Product namePonatinib
    D.3.2Product code AP24534
    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 INNponatinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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) Yes
    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 Yes
    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 RoleComparator
    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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europhatrm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 INNIMATINIB MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Myeloid Leukemia
    Leucemia Mieloide Cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Leukemia
    Leucemia Cronica
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10054352
    E.1.2Term Chronic phase chronic myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
    Confrontare l’efficacia di ponatinib e imatinib attraverso la misurazione del grado di risposta molecolare maggiore (MMR) a 12 mesi (1 mese o ciclo = 28 giorni).
    E.2.2Secondary objectives of the trial
    • To compare, according to treatment with ponatinib versus imatinib, MMR rate at 5 years
    • To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABLIS), in patients administered ponatinib versus those administered imatinib
    • To compare, according to treatment with ponatinib versus imatinib, the complete cytogenetic response (CCyR) rate at 12 months
    • To compare, according to treatment with ponatinib versus imatinib, progression-free survival and overall survival
    • Per confrontare, in base al trattamento con ponatinib rispetto a imatinib, il grado di MMR a 5 anni
    • Confrontare la proporzione di soggetti che a 3 mesi raggiungono un rapporto tra i livelli di trascritto BCR-ABL e ABL &lt; 10% secondo la scala internazionale (&lt; 10% BCR-ABLIS) nei pazienti a cui è stato somministrato ponatinib e quelli a cui è stato somministrato imatinib.
    • Confrontare, secondo il trattamento con ponatinib rispetto a imatinibGrado di risposta citogenetica completa (CCyR, Complete Cytogenetic Response) a 12 mesi.
    • Confrontare, secondo il trattamento con ponatinib rispetto a imatinib, la sopravvivenza libera da progressione e la sopravvivenza globale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ≥18 years old
    2. CP CML within 6 months of diagnosis
    a. CP CML will be defined by
    i <15% blasts in bone marrow
    ii <30% blasts plus promyelocytes in bone marrow
    iii <20% basophils in peripheral blood
    iv ≥100 × 109/L platelets (≥100,000/mm3)
    v No evidence of extramedullary disease except hepatosplenomegaly
    vi No prior diagnosis of accelerated phase (AP) or blast phase (BP) CML
    3. Cytogenetic assessment must demonstrate the BCR ABL fusion by presence of the t(9;22) Philadelphia chromosome
    a. Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques
    b. Conventional chromosome banding must be performed
    c. A minimum of 20 metaphases must be assessable at entry
    4. ECOG Performance Status of 0, 1, or 2
    5. Adequate hepatic function as defined by the following criteria:
    a. Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
    b. Alanine aminotransferase (ALT) ≤2.5 × ULN
    c. Aspartate aminotransferase (AST) ≤2.5 × ULN
    6. Adequate renal function as defined by the following criterion:
    a. Serum creatinine <1.5 × ULN
    7. Adequate pancreatic function as defined by the following criterion:
    a. Serum lipase and amylase ≤1.5 × ULN
    8. For females of childbearing potential, a negative pregnancy test must be documented prior to randomization
    9. Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners from randomization through 30 days after the end of treatment
    10. Provide written informed consent
    11. Willingness and ability to comply with scheduled visits and study procedures
    1. Pazienti di sesso maschile e femminile d’età ≥ 18 anni.
    2. Diagnosi di CP-CML entro 6 mesi dalla diagnosi.
    a. La diagnosi CP-CML sarà definita attraverso:
    i &lt; 15% blasti nel midollo osseo
    ii &lt; 30% blasti + promielociti nel midollo osseo
    iii &lt; 20% basofili nel sangue periferico
    iv ≥ 100 × 109/l piastrine (≥ 100.000/mm3)
    v nessuna evidenza di malattia extramidollare tranne epatosplenomegalia
    vi nessuna precedente diagnosi di CML in fase accelerata (AP, accelerated phase) o in fase blastica (BP, blast phase).
    3. La valutazione citogenetica deve dimostrare la fusione BCR-ABL con la presenza del cromosoma Philadelphia t(9;22).
    a. Traslocazioni varianti sono ammesse solo a patto che siano valutabili per la risposta citogenetica tramite tecniche citogenetiche convenzionali.
    b. È necessario effettuare un bandeggio cromosomico convenzionale.
    c. Al momento dell’arruolamento deve essere verificabile un numero minimo di 20 metafasi.
    4. Performance status (PS) ECOG di 0, 1 o 2.
    5. Funzionalità epatica adeguata come definito dai seguenti criteri:
    a. bilirubina sierica totale ≤ 1,5 x limite superiore di normalità (ULN, upper limit of normal), a meno che non sia presente la sindrome di Gilbert
    b. alanina aminotransferasi (ALT) ≤ 2,5 × ULN
    c. aspartato aminotransferasi (AST) ≤ 2,5 × ULN.
    6. Funzionalità epatica adeguata come definito dal seguente criterio:
    a. creatinina sierica &lt; 1,5 x ULN.
    7. Funzionalità pancreatica adeguata come definito dal seguente criterio:
    a. amilasi e lipasi sierica ≤ 1,5 × ULN.
    8. Per le pazienti di sesso femminile in età fertile, prima della randomizzazione deve essere fornito un test di gravidanza negativo.
    9. I pazienti di sesso maschile e femminile in età fertile devono acconsentire all’uso di un metodo efficace di contraccezione durante i rapporti con i loro partner, dal momento della randomizzazione fino a 30 giorni dopo la fine del trattamento.
    10. Rilascio di un consenso informato in forma scritta.
    11. Volontà e capacità di attenersi alle visite programmate e alle procedure dello studio.
    E.4Principal exclusion criteria
    1. Received prior imatinib therapy
    2. Received prior dasatinib therapy
    3. Received prior nilotinib therapy
    4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
    5. Major surgery within 28 days prior to initiating therapy
    6. History of bleeding disorder unrelated to CML
    7. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
    8. History of alcohol abuse
    9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
    10. Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
    a. Myocardial infarction, unstable angina and/or congestive heart failure within 3 months prior to randomization
    b. History of clinically significant (as determined by the treating physician) atrial arrhythmia; or any ventricular arrhythmia
    11. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic >150 mm Hg)
    12. Taking medications that are known to be associated with Torsades de Pointes (Appendix A)
    13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection
    14. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history
    15. Pregnant or breastfeeding
    16. Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs
    17. Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
    18. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug
    1. Precedente terapia con imatinib.
    2. Precedente terapia con dasatinib.
    3. Precedente terapia con nilotinib.
    4. Qualsiasi altra terapia antitumorale sistemica, terapia sperimentale, o radioterapia (con l’eccezione di anagrelide o idrossiurea) per la CML.
    5. Intervento di chirurgia maggiore nei 28 giorni prima dell’avvio della terapia.
    6. Anamnesi di disturbi emorragici non correlati alla CML.
    7. Anamnesi di pancreatite acuta nell’anno precedente lo studio o anamnesi di pancreatite cronica.
    8. Anamnesi di abuso di alcol.
    9. Ipertrigliceridemia non controllata (trigliceridi &gt; 450 mg/dl) in atto.
    10. Malattia cardiovascolare significativa non controllata o attiva, comprendente in particolare, ma non limitata a:
    a. infarto miocardico, angina instabile e/o insufficienza cardiaca congestizia nei 3 mesi precedenti la randomizzazione
    b. anamnesi di aritmia atriale clinicamente significativa (secondo la valutazione del medico curante) o di qualsiasi aritmia ventricolare.
    11. Ipertensione non controllata (pressione arteriosa diastolica &gt; 100 mm Hg, sistolica &gt; 150 mm Hg).
    12. Assunzione di farmaci di cui è nota l’associazione con la sindrome da Torsades de Pointes (Appendice A).
    13. Infezioni in corso o attive. La necessità di antibiotici endovena (EV) è considerata un’infezione attiva.
    14. Anamnesi accertata di infezione da virus dell’immunodeficienza umana acquisita (HIV). In assenza di tale anamnesi il test non è necessario.
    15. Gravidanza o allattamento al seno.
    16. Sindrome da malassorbimento o altra patologia gastrointestinale che possa interferire con l’assorbimento per via orale dei farmaci in studio.
    17. Diagnosi o trattamento antitumorale ricevuto per un’altra forma maligna primaria nei 3 anni precedenti all’arruolamento (tranne che per tumore della pelle non-melanoma o cancro cervicale in situ).
    18. Qualsiasi condizione o malattia che, secondo l’opinione dello sperimentatore, comprometterebbe la sicurezza del paziente o interferirebbe con la valutazione del farmaco.
    E.5 End points
    E.5.1Primary end point(s)
    MMR rate at 12 months (1 month or cycle = 28 days)
    Grado di MMR a 12 mesi (1 mese o ciclo = 28 giorni).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 months
    a 12 mesi
    E.5.2Secondary end point(s)
    • MMR rate at 5 years
    • <10% BCR ABLIS rate at 3 months
    • CCyR rate at 12 months
    • Progression-free survival
    • Overall survival
    1 Grado di MMR a 5 anni.
    2 Valore di BCR-ABLIS a 3 mesi < 10%.
    3 Grado di CCyR a 12 mesi.
    4 Sopravvivenza libera da progressione.
    5 Sopravvivenza globale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    various
    vari
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Australia
    Hong Kong
    Israel
    Korea, Republic of
    New Zealand
    Singapore
    South Africa
    Switzerland
    Taiwan
    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
    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 months38
    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 months38
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 390
    F.4.2.2In the whole clinical trial 528
    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)
    expanded access/compassionate use
    accesso allargato/uso compassionevole/
    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 Decision2012-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-18
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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