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    Summary
    EudraCT Number:2011-004701-24
    Sponsor's Protocol Code Number:D4200C00097
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-004701-24
    A.3Full title of the trial
    An International, Randomised, Double-Blind, Two-Arm Study to Evaluate the Safety and Efficacy of Vandetanib 150 and 300 mg/day in Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma with Progressive or Symptomatic Disease
    Studio internazionale, randomizzato, in doppio cieco, a due bracci per la valutazione della sicurezza e dell'™efficacia di vandetanib 150 e 300 mg/giorno in pazienti affetti da carcinoma midollare della tiroide localmente avanzato o metastatico non resecabile, con malattia in progressione o sintomatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Compare The Effects Of Two Doses Of Vandetanib In Patients With
    Advanced Medully Thyroid Cancer
    Per confrontare gli effetti di due dosi di Vandetanib In pazienti con carcinama midollare della tiroide localmente avanzato o metastatico non resecabile
    A.4.1Sponsor's protocol code numberD4200C00097
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressConcord Pike,
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 302 885 4928
    B.5.5Fax numberNA
    B.5.6E-mailinformation.centre@astrazeneca.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    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 INNVANDETANIB
    D.3.9.1CAS number 443913-73-3
    D.3.9.2Current sponsor codeZD6474
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB29174
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 No
    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 namena
    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 INNVANDETANIB
    D.3.9.1CAS number 443913-73-3
    D.3.9.2Current sponsor codeZD6474
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB29174
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    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 nameNA
    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 INNVANDETANIB
    D.3.9.1CAS number 443913-73-3
    D.3.9.2Current sponsor codeZD6474
    D.3.9.4EV Substance CodeSUB29174
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Unresectable locally advanced or metastatic medullary thyroid cancer
    carcinoma midollare della tiroide localmente avanzato o metastatico non resecabile
    E.1.1.1Medical condition in easily understood language
    Advanced medullary thyroid cancer
    carcinoma midollare della tiroide localmente avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1
    valutare il tasso di risposta obiettiva (ORR) per 150 mg e 300 mg / die di Vandetanib nei pazienti con MTC localmente avanzato o metastatico. L’ORR è definito come la percentuale di pazienti la cui risposta migliore è una risposta completa (CR) o parziale (PR), (CR / PR) secondo RECIST versione 1.1.
    E.2.2Secondary objectives of the trial
    Safety, tolerability and pharmacokinetics of vandetanib 150 mg and 300mg. Time to and duration of objective response, and best percentage change in target lesion size in Part A. Examine the relationship between PK and QTc
    Sicurezza, la tollerabilità e la farmacocinetica di Vandetanib 150 mg e 300 mg. Tempo e la durata della risposta obiettiva, e il cambiamento migliore percentuale delle dimensioni della lesione target,durante la parte A. esaminare la relazione tra PK e QTc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or have one or more symptoms that the Investigator believes to be related to the patient's MTC. World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. Has measurable disease (at least one lesion, not irradiated within12weeks of study randomisation, with longest diameter ≥10mm (lymph
    nodes minimum ≥15 mm) with CT or MRI). Lesions must be amenable to
    accurate and repeat measurement
    Consenso scritto da pazienti di sesso femminile o maschile di età compresa tra 18 anni e oltre. In precedentemente confermata la diagnosi istologica di non resecabile, localmente avanzato o metastatico, ereditaria o sporadica MTC Obiettivo progressione della malattia nei 14 mesi precedenti l'arruolamento, e / o disporre di uno o più sintomi che lo sperimentatore ritiene essere correlato alla MTC del paziente. Organizzazione Mondiale della Sanità (OMS) o Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. Ha malattia misurabile (almeno una lesione, non irradiata entro 12settimane prima della randomizzazione con diametro maggiore ≥10mm (linfonodi minimo ≥15mm) con TAC e RM . Le lesioni devono essere suscettibili di
    misurazione accurata e ripetuta
    E.4Principal exclusion criteria
    Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization. Abnormal liver function tests (bilirubin>1.5xULRR, and ALT, AST, or ALP>2.5xULRR or 5.0xULRR if related to liver metastases). Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or >450 ms Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance. For women only - currently pregnant or breast feeding.
    Precedenti trattamenti (chirurgia maggiore, radioterapia, chemioterapia, o altri farmaci sperimentali)ricevute entro 28 giorni prima della randomizzazione. Anormali test di funzionalità epatica (bilirubina&gt; 1.5xULRR e ALT, AST, ALP o&gt; 2.5xULRR o 5.0xULRR se riferite a metastasi del fegato). Significative patologie cardiache o di eventi quali la riduzione funzioni cardiache, aritmia cardiaca sintomatica che richiede un trattamento, la sindrome congenita del QT lungo, storia clinica di farmaco-indotta prolungamento del QT, oppure la rettificazione QTcF non misurabile o&gt; 450 ms anormali elettroliti quali potassio, magnesio e calcio, o anormali funzioni organiche quali la riduzione della clearance della creatinina. Donne in stato di gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1
    valutare il tasso di risposta obiettiva (ORR) per 150 mg e 300 mg / die di Vandetanib nei pazienti con MTC localmente avanzato o metastatico. L’ORR è definito come la percentuale di pazienti la cui risposta migliore è una risposta completa (CR) o parziale (PR), (CR / PR) secondo RECIST versione 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient's disease status is measured every 12 weeks for up to14months after start of treatment or objective disease progression if earlier.
    La condizione di malattia del paziente viene misurata ogni 12 settimane per 14 mesi dopo l'inizio del trattamento o fino a progressione della malattia.
    E.5.2Secondary end point(s)
    To evaluate the safety and tolerability of vandetanib 150 mg and 300 mg To evaluate the time to objective response, duration of objective response, and the best percentage change in target lesion (TL) size while in Part A of the study To evaluate the pharmacokinetics (PK) of vandetanib at 150 mg and 300 mg in this patient population To examine the relationship between PK and QTcF (QT interval corrected for heart rate according to Fridericia)is applicable
    valutare la sicurezza e la tollerabilità di Vandetanib 150 mg e 300 mg , valutare il tempo di risposta obiettiva, la durata della risposta obiettiva, e la migliore variazione percentuale di dimensione della lesione target (TL) , mentre nella parte A dello studio per valutare la farmacocinetica (PK) di Vandetanib a 150 mg e 300 mg in questa popolazione di pazienti ad esaminare il rapporto tra PK e QTcF (intervallo QT corretto per la frequenza cardiaca secondo Fridericia) è applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety monitored continuously and evaluated after 14 and 24 months.
    NB treatment is unblinded after 14 months or objective progression
    Disease levels evaluated for 14months after start of treatment or
    objective disease progression if earlier.NB treatment is unblinded after
    14 months or objective progression
    At 3, 8, 12, 24 and 60 weeks after starting treatment and when objective
    disease progession is evident (if <60 weeks)
    Safety monitored continuously and evaluated overall after 14 and 24months. NB treatment is unblinded after 14 months or objective
    progression
    Sicurezza costantemente monitorati e valutati dopo 14 e 24 mesi.
    NB il trattamento è unblinded dopo 14 mesi o con progressione oggettiva
    Livelli di malattia valutati per 14 mesi dopo l'inizio del trattamento o
    progressione della malattia se precedente.NB obiettivo è unblinded dopo
    14 mesi o con una progressione oggettiva
    At settimana 3, 8, 12, 24 e 60 dopo l'inizio del trattamento e quando la
    progession malattia è evidente (se <60 settimane)
    Sicurezza costantemente monitorati e valutati in generale, dopo 14 e 24 mesi. NB il trattamento è unblinded dopo 14 mesi o dopo oggettiva
    progressione
    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 Yes
    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 Yes
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    India
    Israel
    Russian Federation
    United States
    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
    LVLS
    LVLS
    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 months39
    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 months30
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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)
    Following the Final Analysis Visit AstraZeneca will continue to supply
    open-label vandetanib as long as, in the investigator's opinion, the
    patient is benefiting from treatment, or until they are given another
    anti-cancer therapy. However, where local regulations allow, patients
    may be switched from clinical trial supplies to marketed vandetanib in
    those territories where vandetanib is approved for the disease under
    study.
    Dopo la visita finale AstraZeneca analisi continuerà a fornire
    Vandetanib finché, a giudizio del medico, il paziente beneficia del trattamento, o fino a quando non inizia un'altra terapia antitumorale. Tuttavia, dove le normative locali lo consentono, i pazienti
    possono passare a Vandetanib commercializzati in
    quei territori in cui Vandetanib e in commercio per la patologia in
    studio.
    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 Decision2012-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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