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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42771   clinical trials with a EudraCT protocol, of which   7044   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2014-004066-20
    Sponsor's Protocol Code Number:AC-055-403
    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:2015-05-22
    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 number2014-004066-20
    A.3Full title of the trial
    Studio prospettico, multicentrico, a braccio singolo, in aperto, di fase 4 per la valutazione degli effetti del macitentan sul rimodellamento del ventricolo destro nell'ipertensione arteriosa polmonare (Right vEntricular remodeling in Pulmonary ArterIal hypeRtension) accertata mediante risonanza magnetica cardiaca per immagini.
    A prospective, multicenter, single-arm, open-label, Phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IV study on right ventricular remodeling in Pulmonary arterial hypertension
    Studio di fase IV sul rimodellamento del ventricolo destro nell'ipertensione arteriosa polmonare
    A.3.2Name or abbreviated title of the trial where available
    REPAIR
    REPAIR
    A.4.1Sponsor's protocol code numberAC-055-403
    A.5.4Other Identifiers
    Name:AC-055-403Number:AC-055-403
    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 SponsorACTELION PHARMACEUTICALS LTD
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAzienda Farmaceutica: Actelion Pharmaceuticals -
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceurical Ltd.
    B.5.2Functional name of contact pointGlobal Medical Information
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041 61 5658336
    B.5.5Fax number0041 61 5656410
    B.5.6E-mailmedinfo@actelio.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.2.1.1.2Name of the Marketing Authorisation holderACTELION REGISTRATION 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/909
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Arterial Hypertension
    Ipertensione Polmonare Arteriosa
    E.1.1.1Medical condition in easily understood language
    Pulmonary Arterial Hypertension
    Ipertensione Polmonare Arteriosa
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension (PAH).
    Valutare l'effetto del macitentan sulle proprietà emodinamiche e del ventricolo destro nei pazienti affetti da ipertensione arteriosa polomonare (PAH) sintomatica
    E.2.2Secondary objectives of the trial
    To investigate the effect of macitentan on ventriculo-arterial coupling in patients with symptomatic PAH.
    To evaluate the safety and tolerability of macitentan in patients with symptomatic PAH.
    Indagare l'effetto del macitentan sull'accoppiamento ventricolo-arterioso nei pazienti affetti da PAF sintomatica
    Valutare la sicurezza e tollerabilità del macitentan nei pazienti affetti da PAH sintomatica.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Three substudies described in the study protocol.
    The substudies will be performed in the selected studies each one will participate to one each selected subsudy
    - Substudy on metabolism, onlys United States
    -Substudy on biopsy
    -Substudy on echocardiography
    Sono previsti tre sottostudi, descritti nello stesso protocollo.
    I sottostudi saranno effettuati in centri selezionati, ciascuno dei quali parteciperà a un solo sottostudio. In questi centri, tutti i pazienti idonei a partecipare allo studio principale saranno invitati a prendere parte a un sottostudio.
    -Sottostudio sul metabolismo, solo negli Stati Uniti
    -Sottostudio sulla biopsia
    -Sottostudio sull'ecocardiografia
    E.3Principal inclusion criteria
    1. Signed informed consent prior to any study-mandated procedure.
    2. Symptomatic PAH.
    3. World Health Organization (WHO) Functional Class (FC) I to III.
    4. PAH etiology belonging to one of the following groups according to Nice classification:
    1.1 Idiopathic PAH
    1.2 Heritable PAH
    1.3 Drug- and toxin-induced PAH
    1.4.4 PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair.
    5. Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) during screening showing:
    • Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
    o Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 12 mmHg and pulmonary vascular resistance (PVR) ≥ 4 Woods Units (WU) (320 dyn.sec.cm-5) or
    o 12 mmHg ≤ PCWP or LVEDP ≤ 15 mmHg and PVR ≥ 6 WU (480 dyn.sec.cm-5).
    6. 6-minute walk distance (6MWD) ≥ 150 m during screening.
    7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period.
    8. For patients treated with phosphodiesterase type-5 (PDE-5) inhibitors, treatment dose must have been stable at least 3 months prior to RHC during the screening period.
    9. For patients treated with beta blockers, treatment dose must have been stable at least 1 month prior to the RHC during the screening period.
    10. Men or women ≥ 18 and < 65 years.
    11. Women of childbearing potential [see Section 4.5.1] must:
    a. Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
    b. Agree to use reliable methods of contraception [see Section 4.5] from screening up to 30 days after study treatment discontinuation, and
    Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation.
    b. Agree to use reliable methods of contraception [see Section 4.5] from screening up to 30 days after study treatment discontinuation, and
    c. Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation.
    1. Firma del consenso informato prima di qualsiasi procedura richiesta dallo studio.
    2. PAH sintomatica.
    3. Classe funzionale (FC) dell'Organizzazione mondiale della sanità (WHO) II e III.
    4. Eziologia PAH riconducibile a uno dei seguenti gruppi secondo la classificazione Nice:
    1.1 PAH idiopatica
    1.2 PAH ereditabile
    1.3 PAH indotta da farmaci e tossine
    1.4.4 PAH associata a cardiopatie congenite: solo semplici (difetto settale atriale, difetto settale ventricolare, dotto arterioso pervio) con shunt sistemico-polmonare due anni almeno dopo la riparazione chirurgica
    5. Diagnosi emodinamica di PAH confermata dalla
    cateterizzazione cardiaca destra (RHC) durante lo screening che mostri:
    • Pressione arteriosa polmonare media (mPAP) ≥25 mmHg e
    o Pressione wedge (pressione di incuneamento dei capillari polmonari) (PCWP) o pressione telediastolica ventricolare sinistra finale (LVEDP) ≤12 mm Hg e resistenza vascolare polmonare (PVR) ≥4 unità Wood (WU) (320 dyne/sec/cm-5) o
    o 12 mmHg ≤PCWP o LVEDP ≤15 mm Hg e PVR ≥6 WU (480 dyne/sec/cm-5).
    6. Distanza percorsa a piedi in 6 minuti (6MWD) ≥150 m durante lo screening.
    7. Per i pazienti trattati con diuretici orali, la dose di trattamento deve essere rimasta stabile per almeno un mese prima della cateterizzazione cardiaca destra durante il periodo di screening.
    8. Per i pazienti trattati con inibitori della fosfodiesterasi di tipo 5 (PDE-5), la dose di trattamento deve essere rimasta stabile per almeno tre mesi prima della cateterizzazione cardiaca destra durante il periodo di screening.
    9. Per i pazienti trattati con betabloccanti, la dose di trattamento deve essere rimasta stabile per almeno un mese prima della cateterizzazione cardiaca destra durante il periodo di screening.
    10. Uomini o donne ≥18 e <65 anni.
    11. Le donne in età fertile [vedere la sezione 4.5.1] devono:
    a. ottenere un test di gravidanza su siero negativo durante lo screening e un test di gravidanza su urine negativo il giorno 1 e
    b. accettare di usare metodi contraccettivi affidabili [vedere la sezione 4.5] dallo screening fino a 30 giorni dopo che avranno cessato di assumere il farmaco oggetto dello studio e
    c. accettare di eseguire il test di gravidanza ogni mese fino a 30 giorni dopo che avranno cessato di assumere il farmaco oggetto dello studio.
    E.4Principal exclusion criteria
    1. Body weight < 40 kg.
    2. Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI < 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
    3. Pregnancy, breastfeeding, or intention to become pregnant during the study.
    4. Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program.
    5. Known concomitant life-threatening disease with a life expectancy < 12 months.
    6. Any condition likely to affect protocol or treatment compliance.
    7. Hospitalization for PAH within 3 months prior to informed consent signature.
    8. Left atrial volume indexed for body surface area ≥ 43mL/m2 by echocardiography or cardiac MRI.
    9. Valvular disease grade 2 or higher.
    10. History of pulmonary embolism or deep vein thrombosis.
    11. Documented moderate to severe chronic obstructive pulmonary disease.
    12. Documented moderate to severe restrictive lung disease.
    13. Historical evidence of significant coronary artery disease established by:
    o History of myocardial infarction or
    o More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
    o Elevation of the ST segment on electrocardiogram or
    o History of coronary artery bypass grafting or
    o Stable angina.
    14. Diabetes mellitus.
    15. Moderate to severe renal insufficiency (calculated creatinine clearance < 60 mL/min/1.73 m2).
    16. Cancer.
    17. Systolic blood pressure < 90 mmHg.
    18. Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by an aspartate aminotransferase (AST) elevation > ULN at screening.
    19. Hemoglobin < 100g/L.
    20. Serum AST and/or alanine aminotransferase (ALT) > 3 × ULN.
    21. Need for dialysis.
    22. Responders to acute vasoreactivity test based on medical history.
    23. Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues.
    24. Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John’s Wort).
    25. Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir).
    26. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
    27. Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya).
    28. Claustrophobia.
    29. Permanent cardiac pacemaker, automatic internal cardioverter.
    30. Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device).
    31. Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
    32. For patients enrolling in the metabolism sub-study only: glucose intolerance.
    33. For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital heart diseases.
    1. Peso corporeo <40 kg.
    2. Indice di massa corporea (IMC) >35 kg/m2. Per i pazienti con IMC 30 kg/m2 - <35 kg/m2, sarà presentato il modulo di idoneità a un membro del Comitato direttivo che si riserverà il diritto di escludere il paziente.
    3. Gravidanza in corso o programmata e allattamento durante lo studio.
    4. Programma di riabilitazione cardiopolmonare iniziato di recente (<8 settimane dalla firma del consenso informato) o pianificato.
    5. Malattia concomitante nota, pericolosa per la vita, con aspettativa di vita <12 mesi.
    6. Qualsiasi condizione che presumibilmente influisce sulla conformità al protocollo o al trattamento.
    7. Ricovero in ospedale per PAH nei tre mesi precedenti la firma del consenso informato.
    8. Volume atriale sinistro indicizzato per l'area della superficie corporea ≥43 ml/m2 in base a ecocardiografia o RMI cardiaca.
    9. Malattia valvolare grado 2 o superiore.
    10. Storia di embolia polmonare o trombosi venosa profonda.
    11. Pneumopatia ostruttiva cronica documentata da moderata a grave.
    12. Malattia polmonare restrittiva documentata da moderata a grave.
    13. Prova storica di malattia arteriosa coronarica importante determinata in base a:
    o Storia di infarto miocardico o
    o Oltre il 50% di stenosi arteriosa coronarica (mediante intervento coronarico percutaneo o angiografia) o
    o Elevazione del segmento ST nell'elettrocardiogramma o
    o Storia di innesto di bypass aorto-coronarico o
    o Angina stabile.
    14. Diabete mellito.
    15. Insufficienza renale da moderata a grave (clearance della creatinina calcolata <60 ml/min/1,73 m2).
    16. Cancro.
    17. Pressione sanguigna sistolica <90 mm Hg.
    18. insufficienza epatica grave (con o senza cirrosi epatica) in conformità ai criteri della classificazione National Cancer Institute Organ Dysfunction Working Group, definita come bilirubina totale >3 volte il limite superiore del valore normale (ULN) accompagnata da aumento dell'aspartato aminotransferasi (AST) >ULN durante lo screening.
    19. Emoglobina <100 g/l.
    20. AST e/o alanina aminotransferasi (ALT) nel siero >3 volte l'ULN.
    21. Necessità di dialisi.
    22. Responder al test acuto di vasoreattività in base alla storia clinica
    23. Precedente uso di antagonisti dei recettori dell'endotelina (ERA), stimolatori della guanilato ciclasi solubile, prostacicline o analoghi delle prostacicline.
    24. Trattamento con forti induttori dell'isoenzima 3A4 del citocromo P450 (CYP3A4) entro le quattro settimane precedenti l'inizio del trattamento oggetto dello studio (per esempio, carbamazepina, rifampicina, rifabutina, fenitoina e iperico).
    25. Trattamento con forti inibitori del CYP3A4 entro le quattro settimane precedenti l'inizio del trattamento oggetto dello studio (per esempio, ketoconazolo, itraconazolo, voriconazolo, claritromicina, telitromicina, nefazodone, ritonavir e saquinavir).
    26. Trattamento con un altro farmaco sperimentale (pianificato o effettuato entro i tre mesi precedenti l'inizio del trattamento oggetto dello studio).
    27. Ipersensibilità a un qualsiasi ERA o a qualsiasi eccipiente della formulazione del macitentan (lattosio, magnesio stearato, cellulosa microcristallina, povidone, glicolato di amido di sodio, alcool polivinilico, polisorbato, biossido di titanio, talco, gomma xantana e lecitina di soia).
    28. Claustrofobia.
    29. Pacemaker cardiaco permanente, cardiovertitore automatico.
    30. Impianto metallico (per esempio, defibrillatore, neurostimolatore, apparecchio acustico, uso permanente di dispositivo di infusione).
    31. Fibrillazione atriale, contrazioni ventricolari o atriali premature multiple o qualsiasi altra condizione che interferisca con l'adeguato gating cardiaco durante la RMI.
    32. Per i pazienti che partecipano esclusivamente al sottostudio sul metabolismo: intolleranza al glucosio.
    33. Per i pazienti che partecipano esclusivamente al sottostudio sulla biopsia: Eziologia PAH riconducibile alla classificazione Nice 1.4.4: PAH associata a cardiopatie congenite.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoints The study has two primary efficacy endpoints: - Change from baseline to Week 26 in Right Ventricular (RV) Stroke Volume (RVSV) assessed by cardiac MRI from pulmonary artery flow. - Ratio of Week 26 to baseline PVR assessed by RHC.
    Endpoint di efficacia primari Lo studio ha due endpoint di efficacia primari: - Variazione, tra il basale e la settimana 26, dello stroke volume (SV) del ventricolo destro valutata mediante RMI cardiaca in base al flusso dell'arteria polmonare - PVR alla settimana 26 rispetto al basale valutata mediante cateterizzazione cardiaca destra.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 26
    settimana 26
    E.5.2Secondary end point(s)
    Change from baseline to Week 26 in: - RV End Diastolic Volume (RVEDV) - RV End Systolic Volume (RVESV) - RV Ejection Fraction (RVEF) - RV mass - Arterial elastance - RV end-systolic elastance - RV maximum isovolumic pressure - 6MWD - WHO FC
    Variazione tra il basale e la settimana 26 di: - Volume telediastolico (EDV) del ventricolo destro - Volume telesistolico (ESV) del ventricolo destro - Frazione di eiezione (EF) del ventricolo destro - Massa del ventricolo destro - Elastanza arteriosa - Elastanza telesistolica del ventricolo destro - Pressione isovolumetrica massima del ventricolo destro - 6MWD - FC WHO
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 26
    settimana 26
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    France
    Germany
    Netherlands
    United Kingdom
    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 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: 100
    F.1.3Elderly (>=65 years) No
    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 60
    F.4.2.2In the whole clinical trial 100
    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)
    After the patient's study completion or premature withdrawal from the
    study, whichever applies, the investigator/delegate will explain to
    patients what treatment(s)/medical care is necessary and available
    according to local regulations.
    I pazienti continueranno una terapia per la loro patologia in accordo con la pratica clinica nazionale
    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 Decision2015-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA