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    Summary
    EudraCT Number:2012-001398-97
    Sponsor's Protocol Code Number:20110118
    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:2012-09-27
    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 number2012-001398-97
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease
    Studio multicentrico, in doppio cieco, randomizzato e controllato con placebo per valutare l'impatto di una ulteriore riduzione dei livelli di colesterolo LDL sugli eventi cardiovascolari maggiori quando AMG 145 è utilizzato in associazione alla terapia con statine in pazienti con patologia cardiovascolare clinicamente evidente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events when AMG 145 is used in combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease
    Studio per valutare l'impatto della riduzione addizionale del colesterlolo LDL negli eventi cardiovascolari maggiori quando il farmaco AMG145 � usato in combinazione con le statine in pazienti con malattia cardiovascolare clinicamente rilevante
    A.4.1Sponsor's protocol code number20110118
    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 SponsorAMGEN 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Domp� SpA
    B.5.2Functional name of contact pointDip. Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number026241121
    B.5.5Fax number0229005596
    B.5.6E-mailgbotta@amgen.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 nameAMG 145
    D.3.2Product code NA
    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.3.9.2Current sponsor codeAMG 145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dyslipidemia
    Dislipidemia
    E.1.1.1Medical condition in easily understood language
    Abnormal amounts of lipids in the blood
    Quantità anormale di lipidi nel sangue
    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 15.0
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    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 evaluate the effect of treatment with AMG 145, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in subjects with clinically evident cardiovascular disease
    Valutare l'effetto del trattamento con AMG 145 rispetto a placebo sul rischio di decesso cardiovascolare, infarto del miocardio, ictus, ricovero ospedaliero per angina instabile o rivascolarizzazione coronarica, qualunque si verifichi per primo, in soggetti con patologia cardiovascolare clinicamente evidente.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of treatment with AMG 145, compared with placebo, in subjects with clinically evident cardiovascular disease on the risk for: •cardiovascular death, myocardial infarction, or stroke •death by any cause •hospital admissions for worsening heart failure
    Valutare l'effetto del trattamento con AMG 145 rispetto a placebo in soggetti con patologia cardiovascolare clinicamente evidente sul rischio di: o decesso cardiovascolare, infarto del miocardio o ictus o decesso per qualsiasi causa o ricoveri ospedalieri per peggioramento dell'insufficienza cardiaca
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed informed consent •Male or female ≥ 40 to ≤ 80 years of age at signing of informed consent •History of clinically evident cardiovascular disease within 5 years of screening as evidenced by ANY of the following: o diagnosis of myocardial infarction o diagnosis of stroke •History of type 2 diabetes or, if not diabetic, ANY of the following: o age ≥ 65 years (and ≤ 80 years) o index event within 6 months prior to screening o additional diagnosis of myocardial infarction or stroke (prior to and excluding index event) o history of symptomatic peripheral vascular disease (intermittent claudication with ankle-brachial index [ABI] < 0.9, or peripheral vascular revascularization procedure, or amputation due to atherosclerotic disease) o ≥ 2 of the following risk factors:-HDL-C < 40 mg/dL (1.0 mmol/L) for men and < 50 mg/dL (1.3 mmol/L) for women by central laboratory at screening -residual coronary artery disease with ≥ 40% stenosis in ≥ 2 large vessels -hsCRP > 2.0 mg/L by central laboratory at screening -current smoker -age > 60 years -history of non-MI related coronary revascularization* -final LDL-C > 130 mg/dL (3.4 mmol/L) or non-HDL-C ≥ 160 mg/dL (4.1 mmol/L) by central laboratory during screening -metabolic syndrome, defined as ≥ 3 of the following: - waist circumference > 102 cm (> 40 in.) for men and > 88 cm (> 35 in.) for women - triglycerides ≥ 150 mg/dL (1.7 mmol/L) by central laboratory at screening - HDL-C < 40 mg/dL (1.0 mmol/L) for men and < 50 mg/dL (1.3 mmol/L) for women by central laboratory at screening (Note: if the HDL-C level is one of criterion used to make the diagnosis of metabolic syndrome, it cannot be used as a separate risk factor) - blood pressure (BP) ≥ 130 / ≥ 85 mmHg - fasting glucose ≥ 110 mg/dL by central laboratory at screening •Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mg/dL) by central laboratory during screening after ≥ 4 weeks of stable dose of 20 mg, 40 mg, or 80 mg QD atorvastatin, with or without ezetimibe 10 mg QD •Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by central laboratory at screening
    Uomini e donne ≥40 e ≤80 anni di età sono eleggibili per questo studio. Per essere inclusi, i soggetti devono avere un’anamnesi di patologia cardiovascolare clinicamente evidente, come documentato da un recente (entro 5 anni) ictus o infarto del miocardio; un’anamnesi di diabete di tipo 2 oppure, se non diabetici, una delle seguenti condizioni: età ≥65 anni, index event entro 6 mesi dallo screening, un ulteriore IM o ictus (escluso l’index event) precedente, un’anamnesi di malattia vascolare periferica sintomatica oppure ≥2 ulteriori fattori di rischio, come illustrato nel protocollo dello studio. Inoltre, dopo ≥4 settimane di una dose stabile di atorvastatina tra 20 mg e 80 mg PO QD, con o senza ezetimibe 10 mg PO QD, il valore di LDL-C deve essere ≥70 mg/dl (≥1,8 mmol/l) oppure il valore di non-HDL-C deve essere ≥100 mg/dl (&gt;2,6 mg/dl). I trigliceridi a digiuno devono essere ≤400 mg/dl (4,5 mmol/l).(Per maggiori dettagli fare riferimento al Protocollo di Studio).
    E.4Principal exclusion criteria
    •NYHA class III or IV, or last known left ventricular ejection fraction < 30%•Known hemorrhagic stroke•Uncontrolled or recurrent ventricular tachycardia•Planned or expected cardiac surgery or revascularization within 3months after randomization•Uncontrolled hypertension defined as sitting systolic blood pressure (SBP)>180 mmHg or diastolic BP(DBP)>110 mmHg•In the 6 weeks prior to LDL-C screening, subject has taken red yeast rice, >200 mg/day niacin, or prescription lipid-regulating drugs (eg,bile-acid sequestering resins, fibrates and derivatives) other than statins or ezetimibe•Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 months prior to randomization•Prior use of PCSK9 inhibition treatment other than AMG 145 •Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) < 1.0 time the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening •Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at screening •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by central laboratory analysis at screening •Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow) •Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years •CK > 5 times the ULN at screening •Known active infection or major hematologic, renal, metabolic,gastrointestinal or endocrine dysfunction in the judgment of the investigator•Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years•Subject has received drugs that are strong inhibitors of cytochrome P-450 3A4 within 1 month prior to randomization or is likely to require such treatment during the study period •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)•Female subject who has either (1) not used at least 1 highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal; -menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female ≥55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle stimulating hormone (FSH)level >40IU/L (or according to the definition of''postmenopausal range''for the laboratory involved) in a female <55 years old unless the subject has undergone bilateral oophorectomy-highly effective methods of birth control include not having intercourse or using birth control methods that work at least 99% of the time when used correctly and include:birth control pills,shots, implants, or patches,intrauterine devices (IUDs),tubal ligation/occlusion, sexual activity with a male partner who has had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide•Subject is pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 15 weeks after the end of treatment•Known sensitivity or intolerance to any of the products to be administered during dosing or to any statin•Subject will not be available for protocol-required study visits or procedures,to the best of the subject and investigator's knowledge•Subject has any kind of disorder that,in the opinion of the investigator,may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
    I principali criteri di esclusione sono l'appartenenza alla classe III o IV della New York Heart Failure Association (NYHA) oppure l’ultima frazione di eiezione ventricolare sinistra nota &lt;30%; tachicardia ventricolare non controllata o ricorrente, pressione arteriosa sistolica (SBP) &gt;180 mmHg oppure pressione arteriosa diastolica (DBP) &gt;110 mmHg; ormone stimolante la tiroide &lt;1,0 volta il limite più basso del normale (LLN) oppure &gt;1,5 volte il limite più alto del normale (ULN), velocità di filtrazione glomerulare stimata (eGFR) &lt;20 ml/min/1,73 m2, aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) &gt;2x ULN, creatina chinasi (CK) &gt;5x ULN; ricevente di un trapianto di organi vitali (ad esempio, polmone, fegato, cuore, midollo osseo), grave patologia non cardiovascolare concomitante che ci si aspetta riduca l'aspettativa di vita a meno di 3 anni; anamnesi nota di ictus emorragico; infezione attiva importante oppure disfunzione ematologica, renale, metabolica, gastrointestinale o endocrina maggiore; utilizzo di un trattamento di inibizione della proteina di trasferimento del colesteril-estere (CETP) nei 12 mesi precedenti la randomizzazione; precedente utilizzo di un trattamento per l'inibizione della PCSK9 diverso da AMG 145. Le seguenti terapie antilipidiche sono escluse per 6 settimane prima dello screening e per tutta la durata dello studio: farmaci su prescrizione per la regolazione dei livelli di lipidi diversi dalle statine e dall'ezetimibe (ad es. resine sequestranti gli acidi biliari, fibrati e derivati), niacina (&gt;200 mg QD) e lievito di riso rosso.Le donne che prendono parte allo studio non possono rimanere incinta né allattare al seno e le donne in pre-menopausa potenzialmente fertili devono accettare di utilizzare almeno un metodo contraccettivo altamente efficace durante il trattamento e per ulteriori 15 settimane dopo il termine del trattamento.(Per maggiori dettagli fare riferimento al Protocollo di Studio).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first.
    L'endpoint primario è il tempo al decesso cardiovascolare, infarto del miocardio, ricovero ospedaliero per angina instabile, ictus o rivascolarizzazione coronarica, qualunque si verifichi per primo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first.
    L'endpoint primario è il tempo al decesso cardiovascolare, infarto del miocardio, ricovero ospedaliero per angina instabile, ictus o rivascolarizzazione coronarica, qualunque si verifichi per primo.
    E.5.2Secondary end point(s)
    •time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first •time to death by any cause •time to first hospitalization for worsening heart failure
    Gli endpoint secondari sono: • Tempo al decesso cardiovascolare, infarto del miocardio o ictus, qualunque si verifichi per primo. • Tempo al decesso per qualsiasi causa • Tempo al primo ricovero ospedaliero per il peggioramento dell'insufficienza cardiaca
    E.5.2.1Timepoint(s) of evaluation of this end point
    •time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first •time to death by any cause •time to first hospitalization for worsening heart failure
    Gli endpoint secondari sono: • Tempo al decesso cardiovascolare, infarto del miocardio o ictus, qualunque si verifichi per primo. • Tempo al decesso per qualsiasi causa • Tempo al primo ricovero ospedaliero per il peggioramento dell'insufficienza cardiaca
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker development
    Sviluppo di Biomarcatori
    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 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 Yes
    E.8.1.7.1Other trial design description
    Studio di outcome cardiovascolare
    Cardiovascular outcomes study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    European Union
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Hong Kong
    India
    Israel
    Japan
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    New Zealand
    Philippines
    Russian Federation
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    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
    The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the first secondary endpoint (composite of cardiovascular death, myocardial infarction, or stroke). It is expected that at time, approximately 3550 subjects will have experienced an event adjudicated as qualifying for primary endpoint (composite of cardiovascular death, myocardial infarction, stroke, hospitalizat. for unstable angina,coronary revascular
    Lo studio terminerà quando almeno 1.630 soggetti avranno riportato un eventoqualificato come endpoint secondario di decesso cardiovascolare, infarto del miocardio o ictus.(Vedere il protocollo per maggiori dettagli)
    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 months58
    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 months58
    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: 13500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9000
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7627
    F.4.2.2In the whole clinical trial 22500
    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)
    Subjects may be eligible for continued treatment with Amgen IP by an extension protocol or as provided for by the local country's regulatory mechanism. However, Amgen reserves the unilateral right, at its sole discretion, to determine whether to supply Amgen IP, and by what mechanism, after termination of the trial and before it is available commercially.
    I soggetti potrebbero essere eleggibili per continuare il trattamento con il farmaco Amgen in un protocollo di estensione o in altro modo come previsto dalle regolamentazioni locali. Comunque Amgen si riserva il diritto unilaterale, a sua discrezione, di decidere se fornire il farmaco Amgen, e con quale meccanismo, dopo la fine dello studio e prima che sia disponibile sul mercato.
    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 Decision2012-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
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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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