Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002225-10
    Sponsor's Protocol Code Number:EMPA-HEART
    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:2021-06-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002225-10
    A.3Full title of the trial
    Impact of empagliflozin on left ventricular functions: a single center, phase III, randomized, open-label, active treatment-controlled, parallel study in patients with type 2 diabetes and normal left ventricular function
    Impatto di empagliflozin sulle funzioni del ventricolo sinistro: uno studio monocentrico, di fase III, in aperto, con controllo attivo, a gruppi paralleli in pazienti con diabete di tipo 2 e normale funzione ventricolare sinistra
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of empagliflozin on left ventricular functions
    Impatto di empagliflozin sulle funzioni del ventricolo sinistro
    A.3.2Name or abbreviated title of the trial where available
    EMPA-HEART
    EMPA-HEART
    A.4.1Sponsor's protocol code numberEMPA-HEART
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBOEHRINGER INGELHEIM
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportDip. Medicina Clinica e Sperimentale Univ. Pisa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationU.O. Medicina Interna 1
    B.5.2Functional name of contact pointU.O. Medicina Interna 1
    B.5.3 Address:
    B.5.3.1Street AddressVia Roma 67
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56100
    B.5.3.4CountryItaly
    B.5.4Telephone number050992814
    B.5.5Fax number050553235
    B.5.6E-mailandrea.natali@med.unipi.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name JARDIANCE - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJARDIANCE
    D.3.2Product code JARDIANCE
    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 INNEMPAGLIFLOZIN
    D.3.9.1CAS number 864070-44-0
    D.3.9.2Current sponsor codeEMPAGLIFLOZIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TESAVEL - 100 MG COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (PVC/PE/PVDC/ALU) 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTESAVEL
    D.3.2Product code TESAVEL
    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 INNSITAGLIPTIN
    D.3.9.1CAS number 486460-32-6
    D.3.9.2Current sponsor codeSITAGLIPTIN
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    type 2 diabetes
    diabete di tipo 2
    E.1.1.1Medical condition in easily understood language
    type 2 diabetes
    diabete 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 verify whether, in type 2 diabetic patients with normal 2-D ejection fraction (=50%) and without inducible myocardial ischemia at the cardiopulmonary test, the treatment with empagliflozin is associated with an improvement in left ventricular systolic function, as measured by global lungitudinal strain (GLS) through speckle tracking echography, in comparison to sitagliptin, an equally effective plasma glucose lowering agent, presumably neutral on cardiac function
    Verificare se, in pazienti diabetici di tipo 2 con normale frazione di eiezione 2-D (=50%) e senza ischemia miocardica inducibile, il trattamento con empagliflozin sia associato ad un miglioramento della funzione sistolica ventricolare sinistra, misurata mediante il global longitudinal strain (GLS) attraverso l'ecografia spekle tracking, in comparazione a sitagliptin, un agente ipoglicemizzante ugualmente efficace, ma presumibilmente neutro sulla funzione miocardica
    E.2.2Secondary objectives of the trial
    ¿ Changes from baseline at 6 months after treatment initiation in HbA1c;
    ¿ Changes from baseline at 1 and 6 months after treatment initiation in other well established parameters of cardiac function, such as 3-D ejection fraction, left atrial volume, and E/E'.
    ¿ Changes from baseline at 6 months after treatment initiation in VO2 max (Cardiopulmonary exercise test), an extremely clinically relevant parameter that will help in appreciating the relevance of the imaging data.
    A) Accertare l¿effetto del trattamento sui livelli di HbA1c;
    B) Verificare l¿effetto del trattamento su:
    ¿ Parametri di funzione sistolica e diastolica in ecografia 3D;
    ¿ Biomarcatori plasmatici orientati ai meccanismi;
    ¿ VO2 massima;
    ¿ Funzione autonomica cardiaca.
    C) verificare se gli effetti del trattamento differiscono nel sottogruppo di pazienti con lievi anomalie nella funzione sistolica cardiaca al baseline;
    D) rilevare nella intera coorte la relazione tra i cambiamenti negli indici di funzione cardiaca (global longitudinal strain o 3D) e i concomitanti cambiamenti in pressione sanguigna, peso e controllo metabolico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male of female patients affected by type 2 diabetes mellitus (T2DM)
    • Subjects aged >40 and <80 years
    • HbA1c levels =53 and = 69 mmol/mol
    • Assuming stable hypoglycemic therapy since three months with:
    • Metformin
    • Metformin + basal insulin
    • Assuming stable cardio-active therapies since three months (anti-hypertensive drugs, diuretics, drugs for asthma, drugs for migraine)
    • With preserved kidney function as defined by eGFR =45 ml.min-1.1.73m2
    • With preserved left ventricular function as defined by (NYHA class 1-2, and EF=50%)
    pazienti maschi o femmine affetti da diabete mellito di tipo 2 (T2DM); soggetti di età <40 e >80 anni; valori di HbA1c =53 e = 69 mmol/mol; che stiano assumendo terapia ipoglicemizzante stabile da tre mesi con metformina o metformina+insulina basale; che stiano assumendo terapie cardioattive stabili da tre mesi (farmaci anti-ipertensivi, diuretici, farmaci per l’asma, farmaci per l’emicrania); con funzione renale preservata, definita come eGFR =45 ml/min/1.1.73m2; con funzione del ventricolo sinistro preservata, definita da classe NYHA 1-2 ed EF>50%.
    E.4Principal exclusion criteria
    • Refuse to give or inability to give informed consent;
    • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
    • Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator;
    • Patients with type 1 diabetes mellitus;
    • Pregnancy or active breast feeding;
    • History of acute coronary syndrome;
    • Respiratory insufficiency or history of clinically significant respiratory diseases (chronic obstructive pulmonary disease);
    • Acute or chronic inflammatory diseases;
    • History of active neoplastic disease within the last 5 years;
    • Patients with known hypersensitivity to empagliflozin and its excipients;
    • Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (abuse of diuretics or laxatives, chronic diarrhoea etc);
    • History of recurrent or serious genitor-urinary infections;
    • Patients with known hypersensitivity to sitagliptin and its excipients;
    • History of acute or chronic pancreatic disease;
    • Patients who received any investigational new drug within the last 12 weeks;
    • Severe obesity (BMI=40 kg/m2);
    • Uncontrolled blood pressure, defined as >160/100 mmHg;
    • eGFR<45 ml/min/1.73 m2;
    • Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL;
    • Cardiac arrhythmia (2nd grade AV block, atrial fibrillation, peace maker, high incidence premature beats);
    • Clinically relevant cardiac valvular disease;
    • Ejection fraction <50% or presence of regional left ventricular contraction impairment;
    • Poor quality of echocardiographic imaging;
    • Inability to perform the cardiopulmonary exercise test;
    • Evidence of inducible myocardial ischemia at the cardiopulmonary test
    - rifiuto o incapacità di dare il consenso informato;
    - pazienti che verosimilmente non si atterranno al protocollo o incapaci di comprendere la natura, lo scopo e le possibili conseguenze dello studio; - impiegati dello sperimentatore o del centro dello studio (ad esempio lo sperimentatore principale, sotto-sperimentatori, coordinatori dello studio, altri membri dello staff, impiegati o contrattisti di qualunque tipo) che abbiano un coinvolgimento diretto con lo studio proposto o in altri studi sotto la direzione di quello stesso sperimentatore e/o il centro dello studio, così come familiari degli impiegati o dello sperimentatore;
    - pazienti con da diabete mellito di tipo 1;
    - gravidanza o allattamento al seno attivo;
    - storia di sindrome coronarica acuta;
    - insufficienza respiratoria o storia di malattie respiratorie clinicamente significative (malattia ostruttiva cronica polmonare);
    - malattie infiammatorie acute o croniche;
    - storia di malattie neoplastiche attive durante gli ultimi 5 anni; pazienti con nota ipersensibilità a empagliflozin e ai suoi eccipienti;
    - pazienti ipovolemici o coloro che, secondo il giudizio dello sperimentatore, possano essere a rischio di disidratazione (abuso di diuretici o lassativi, diarrea cronica o altri);
    - storia di infezioni genitourinarie ricorrenti o gravi; - pazienti con ipersentibilità nota a sitagliptin e ai suoi eccipienti;
    - storia di malattie pancreatiche acute o croniche; - pazienti che abbiano assunto qualunque nuovo farmaco sperimentale durante le ultime 12 settimane; - obesità grave (BMI>=40kg/m2); - ipertensione arteriosa non controllata, definita come >160/100 mmHg; - eGFR<45 ml/min/1.73m2; insufficienza epatica severa e/o funzione epatica significativamente alterata definita come aspartato-aminotransferasi (AST) > 3x il limite superiore del normale e/o alanina-aminotransferasi (ALT) > 3x il limite superiore del normale o bilirubina totale >2,0 mg/dL; - aritmie cardiache (blocco atrioventricolare di II grado, fibrillazione atriale, pacemaker, battiti prematuri ad elevata incidenza); - valvulopatie clinicamente rilevanti; frazione di eiezione <50% o presenza di disfunzione della contrattilità regionale del ventricolo sinistro; - immagini ecocardidografiche di scarsa qualità; impossibilità di effettuare il test cardiopolmonare; evidenza di ischemia inducibile al test cardiopolmonare
    E.5 End points
    E.5.1Primary end point(s)
    Changes in global longitudinal strain (GLS) from baseline to 1 month and 6 months after treatment initiation.
    Variazione in global longitudinal strain (GLS) dal basale al controllo ad un mese e a sei mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to 1 month and 6 months after treatment initiation
    dal basale al controllo ad un mese e sei mesi
    E.5.2Secondary end point(s)
    - Changes from baseline at 6 months after treatment initiation in
    1) HbA1c;
    2) ejection fraction, left atrial volume and E/E', as measured at 3-D echocardiography;
    3) VO2 max, as measured at cardiopulmonary test;
    4) myocardial parietal stress plasma biomarker (BNP, NT-proBNP, proadrenomedullin), inflammation/oxidative stress plasma biomarkers (hsCRP, TNF-alpha, mieloperoxidase, uric acid) and cardiac remodeling/cytolysis (type III pro-collagene, troponine);
    5) Cardiac autonomic function tests (R-R interval during Valsalva manoeuvre, deep-breathing, lying-to-standing).
    Variazioni rispetto al basale a 6 mesi dall¿inizio del trattamento in:
    1) HbA1c;
    2) frazione di eiezione, volume atriale sinistro ed E/E', misurati con ecocardiografia 3D;
    3) VO2 max, misurata al test cardiopolmonare;
    4) marcatori di stress parietale miocardico (BNP, NT-proBNP, proadrenomedullina), marcatori di infiammazione/stress ossidativo (hsCRP, TNF-alfa, mieloperossidasi, acido urico), marcatori di rimodellamento/citolisi (procollagene tipo III, troponina);
    5) test di funzione autonomica cardiaca (intervallo RR durante manovra di Valsalva, respirazione profonda, clino-ortostatismo).
    E.5.2.1Timepoint(s) of evaluation of this end point
    from baseline at 6 months
    rispetto al basale a 6 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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)
    At the end of the study, the enrolled subjects can continue or discontinue the study treatment on their own preferences and the physician¿s clinical judgment, on the bases of common clinical practice (if well tolerated and effective).

    Alla fine dello studio , i soggetti arruolati possono continuare o interrompere il trattamento studio sulle proprie preferenze e giudizio clinico del medico , sulla base della comune pratica clinica ( se ben tollerato ed efficace )
    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 Decision2016-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Apr 30 08:00:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA