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    Summary
    EudraCT Number:2015-001831-18
    Sponsor's Protocol Code Number:LPS13931
    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:2021-01-21
    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 number2015-001831-18
    A.3Full title of the trial
    A twenty six week, randomized,open-label, 2-armparallel group real world pragmatic trial to assess the clinical and health outcomes benefit of Toujeo compared to standard of care insulin for initiating basel insulin in insulin Naive patients with uncontrolled type 2 diabetes mellitus, with 6 month extension.
    Studio pragmatico nel mondo reale della durata di ventisei settimane, randomizzato, in aperto, su 2 gruppi paralleli, per valutare il beneficio in termini di risultati clinici e lo stato di salute ottenuto con l¿utilizzo di Toujeo rispetto al trattamento con insulina basale standard in pazienti insulino Naive che stanno iniziando il trattamento con insulina basale affetti da diabete mellito di tipo 2 non controllato, con estensione di 6 mesi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A "Real World" Trial to determine efficacy and health outcomes of Toujeo compared to "standard of care" basal insulins in insulin naive patients initiating insulin.
    Uno Studio pragmatico nel mondo reale per determinare l¿efficacia e i risultati clinici di Toujeo rispetto al trattamento con insulina basale standard in pazienti che iniziano per la prima volta il trattamento con insulina.
    A.3.2Name or abbreviated title of the trial where available
    Reach - Control
    Reach - Control
    A.4.1Sponsor's protocol code numberLPS13931
    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 SponsorSANOFI-AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 supportsanofi-aventis Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.p.A.
    B.5.2Functional name of contact pointContact point
    B.5.3 Address:
    B.5.3.1Street AddressViale L. Bodio 37/b
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0039 02 39394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 Yes
    D.2.1.1.1Trade name Toujeo
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULINA GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901-U300
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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 No
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 tutte le insuline appartenenti ai gruppi ATC A10AC e A10AE
    D.2.1.1.2Name of the Marketing Authorisation holder-
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Type 2 Diabetes Mellitus
    Diabete Mellito di tipo 2
    E.1.1.1Medical condition in easily understood language
    type 2 diabetes mellitus.
    diabete mellito di tipo 2.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate non-inferiority of Toujeo versus ¿standard of care¿ basal insulin therapy measured as HbA1c change.
    Dimostrare la non inferiorit¿ di Toujeo rispetto alla terapia standard con insulina basale misurata attraverso la variazione della HbA1c dal basale al mese 6.
    E.2.2Secondary objectives of the trial
    ¿ Superiority of Toujeo versus ¿standard of care¿ basal insulin if non- inferiority is met, measured as HbA1c change.
    ¿ Patient persistence with assigned basal insulin therapy for the overall period, ie, from beginning to the end of the trial with or without intensification,
    ¿ Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events (as defined by the ADA Workgroup on Hypoglycemia.
    ¿ Change in HbA1c at month 12.
    ¿ Change in fasting plasma glucose (FPG)
    ¿ Change in body weight
    ¿ Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc)
    ¿ Change in hypoglycemia control subscale (HCS)
    ¿ Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
    ¿ Superiorit¿ di Toujeo rispetto alla terapia standard con insulina basale se il criterio di non inferiorit¿, misurato attraverso la variazione della HbA1c dal basale al mese 6, sar¿ stato soddisfatto.
    ¿ Permanenza del paziente in terapia con insulina basale prescritta per l'intero periodo, vale a dire dall'inizio fino alla fine della sperimentazione con o senza intensificazione.
    ¿ Rischio di ipoglicemia ivi compresa ipoglicemia sintomatica documentata o grave (secondo il gruppo di lavoro sull¿ ipoglicemia ADA)
    ¿ Variazione della HbA1c al mese 12.
    ¿ Variazione della glicemia a digiuno (FPG).
    ¿ Variazione del peso corporeo.
    ¿ Differenze nei risultati riferiti dal paziente misurati mediante il Diabetes Treatment Satisfaction Questionnaire, versioni Status e Change (DTSQs e DTSQc).
    ¿ Variazione della sottoscala di controllo dell'ipoglicemia (HCS).
    ¿ Utilizzo di Strutt.Sanit.,compresi ricoveri/visite in pronto soccorso, presso altri operatori sanitari e costi dell'assistenza sanitaria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (= 6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, alphaglucosidase inhibitor), and with or without GLP-1 receptor agonist, and eligible to basal insulin treatment, per investigator’s judgment.
    - Adult patients who have signed an informed consent form anda privacy form(s)
    - Pazienti con diabete di tipo 2 non sufficientemente controllato (HbA1c >7%) attualmente in terapia (=6 mesi) con farmaci orali (metformina, sulfoniluree, tiazolidinedione, inibitori della DPP-4, inibitori del SGLT-2, glinidi,inibitori delle alfa-glucosidasi) e con o senza l'uso degli agonisti del recettore del GLP-1 e, a giudizio del medico, eleggibili a ricevere il trattamento con insulina.
    - Pazienti adulti che hanno firmato il consenso informato
    E.4Principal exclusion criteria
    • HbA1c =7%, no upper bound,
    • Age <18 years,
    • Type 1 diabetes mellitus,
    • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study,
    • Use of any product containing insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization (insulin glargine, Lantus, Levemir, Toujeo Tresiba, Humulin or biosimilar, Humalog , Novolog , Apidra , Afrezza , pre-mix insulin, or other insulin products which become available),
    • Use of any product containing insulin occurring within 3 months prior to the time of screening
    • Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
    • All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products.
    • Pregnancy or lactation,
    • Women of childbearing potential with no effective contraceptive method
    • Hypersensitivity to insulin glargine or Toujeo excipients
    · HbA1c =7%, nessun limite superiore.
    · Età <18 anni.
    · Diabete mellito di tipo 1.
    · Qualsiasi alterazione clinicamente significativa identificata in sede di esame obiettivo, test di laboratorio o segni vitali al momento dello screening o qualsiasi importante malattia sistemica risultante in una aspettativa di vita breve che, secondo l'opinione dello sperimentatore, potrebbe restringere o limitare la partecipazione del paziente per tutta la durata dello studio,
    · Uso di un qualsiasi prodotto contenente insulina dal momento della diagnosi di T2DM (quali insulina glargine, Lantus, Levemir, Toujeo, Tresiba, Humulin o biosimilare, Humalog®, Novolog®, Apidra®, Afrezza®, insulina premiscelata, o altri prodotti che potrebbero essere disponibili in commercio) eccezion fatta per un uso temporaneo durante la gravidanza o un ricovero,
    · Uso di qualsiasi prodotto contenente insulina entro 3 mesi prima dello screening
    · Uso di agenti ipoglicemizzanti orali diversi da quelli indicati nei criteri di inclusione, agonisti del recettore del GLP-1 non approvati per l'uso con insulina o qualsiasi prodotto sperimentale (farmaco, biologico, dispositivo) nei 3 mesi precedenti lo screening.
    · Tutte le controindicazioni alla terapia con insulina standard disponibile in commercio o le avvertenze/precauzioni d'uso indicate nella relativa etichettatura nazionale di questi prodotti.
    · Gravidanza o allattamento
    · Donne in età fertile che non utilizzano alcun metodo contraccettivo
    · Ipersensibilità all'insulina glargine o agli eccipienti di Toujeo
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in HbA1c
    Variazione % della HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to 6 months
    dal basale al 6° mese
    E.5.2Secondary end point(s)
    Proportion of patient who remain on assigned basal insulin therapy beforem intensification (persistent with assigned therapy); Proportion of patients who remain on assigned basal insulin therapy wheter intensification occured or not; Proportion pf patients who achieve a target HbA1c of(<6,5%, <7%, <7,5%,<8,0%) al mese 6 e al mese 12; Porportion of patients with HbA1c target (threshold listed above; attainment of metabolic benefit) withou documented (BG =70 mg/dL [=3,9 mmol/L]) symptomatic or severe hipoglycemia; Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dl, [3.0 mmol/L]) symptomatic or severe hypoglycemia; Percentage of patients whose HbA1c decreased at least 1%; Percentage of patients whose HbA1c decreased at least 1%; Percentage of patients requiring intensification and time to intensification ; Change in fasting plasma glucose; Percent change in HbA1c
    Proporzione di pazienti che continua ad assumere la terapia con insulina basale assegnata prima dell'intensificazione (persistenti alla terapia assegnata) al mese 6 e al mese 12; Proporzione di pazienti che continua ad assumere la terapia con insulina basale, indipendentemente che l'intensificazione sia avvenuta o meno; Proporzione di pazienti che raggiunge il livello target di HbA1c (<6,5%, <7%, <7,5%,<8,0%) al mese 6 e al mese 12; Proporzione di pazienti con HbA1c target (soglie limite summenzionate) (raggiungimento del vantaggio metabolico) al mese 6 e al mese 12 senza ipoglicemia documentata (BG =70 mg/dL [=3,9 mmol/L]) sintomatica o grave ; Proporzione di pazienti con HbA1c target (soglie limite summenzionate) (raggiungimento del vantaggio metabolico) al mese 6 e al mese 12 senza ipoglicemia documentata (BG <54 mg/dl, [3,0 mmol/l]) sintomatica o grave ; Percentuale di pazienti la cui HbA1c ¿ diminuita di almeno l¿ 1% al mese 6 e al mese 12; Percentuale di pazienti la cui HbA1c ¿ diminuita di almeno l¿ 1% al mese 6 e si ¿ mantenuta costante al mese 12; Percentuale di pazienti che necessita di intensificazione al mese 6 e al mese 12, e tempo all'intensificazione; Variazione della glicemia a digiuno dal basale al mese 6 e al mese 12; Variazione della HbA1c (%)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at month 6 and month 12; at month 6 and at month 12; at month 6 and month 12; at month 6 and month 12; at month 6 and month 12; at month 6 and month 12; at month 6 and maintained at month 12; at month 6 and month 12; baseline to month 6 and month 12; Baseline to month 12
    al mese 6 e al mese 12; al mese e al mese 12; al mese 6 e al mese 12; al mese 6 e al mese 12; al mese 6 e al mese 12; al mese 6 e al mese 12; al mese 6 e mantenuta al mese 12; al mese e al mese 12; dal basale al mese 6 e al mese 12; dal basale al mese 12
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA156
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    France
    Germany
    Greece
    Ireland
    Italy
    Mexico
    Romania
    Spain
    United Kingdom
    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 months22
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days6
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 680
    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)
    NONE
    NESSUNO
    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 Decision2015-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
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