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   43931   clinical trials with a EudraCT protocol, of which   7307   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:2020-002340-23
    Sponsor's Protocol Code Number:MEIN/19/ZoNe-HYP/001
    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:2021-06-07
    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 number2020-002340-23
    A.3Full title of the trial
    Open-label, multicenter, multinational, interventional clinical trial to assess effectiveness and safety of the extemporaneous combination of nebivolol and zofenopril calcium in grade 1 to 2 hypertensive patients versus each monotherapy
    Sperimentazione clinica interventistica, in aperto, multicentrica, multinazionale per valutare l’efficacia e la sicurezza dell'associazione estemporanea di nebivololo e zofenopril calcio in pazienti affetti da ipertensione di grado 1 o 2, rispetto a ciascuna monoterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and safety of combination of nebivolol and zofenopril calcium in mild to moderate hypertensive patients
    Efficacia e sicurezza della combinazione di nebivololo e zofenopril calcio in pazienti affetti da ipertensione da lieve a moderata
    A.3.2Name or abbreviated title of the trial where available
    MASACCIO
    MASACCIO
    A.4.1Sponsor's protocol code numberMEIN/19/ZoNe-HYP/001
    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 SponsorMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
    B.1.3.4CountryLuxembourg
    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 supportMenarini International Operations Luxembourg SA
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenarini
    B.5.2Functional name of contact pointClinical Operation Director
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi 1-3
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number+39055568091
    B.5.6E-mailpfabrizzi@menarini.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 LOBIVON - 28 COMPRESSE 5 MG
    D.2.1.1.2Name of the Marketing Authorisation holderA. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
    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 nameNebivolol
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEBIVOLOLO
    D.3.9.1CAS number 99200-09-6
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB09175MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 ZOPRANOL - 28 COMPRESSE RIVESTITE CON FILM 30 MG IN BLISTER (PVDC/PVC/AL)
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORI GUIDOTTI S.P.A.
    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 nameZofenopril calcium
    D.3.2Product code [na]
    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 INNZOFENOPRIL CALCIO
    D.3.9.1CAS number 81938-43-4
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB05191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Grade 1 and 2 hypertension
    Ipertenzione di grado 1 e 2
    E.1.1.1Medical condition in easily understood language
    Hypertension
    Ipertensione
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular 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 assess the antihypertensive effect of the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg in lowering sitting diastolic blood pressure (DBP) after 8 weeks of treatment, in patients with uncontrolled blood pressure (BP) who were previously treated with nebivolol or zofenopril calcium monotherapies for at least 4 weeks
    ¿ Valutare l’effetto antipertensivo della combinazione estemporanea di NEB 5 mg e ZOF 30 mg nel ridurre la PAD in posizione seduta dopo 8 settimane di trattamento in pazienti con PA non controllata, precedentemente trattati con monoterapia NEB o ZOF per almeno 4 settimane.
    E.2.2Secondary objectives of the trial
    To assess the antihypertensive effect of the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg in lowering sitting systolic blood pressure (SBP) after 8 weeks of treatment in patients with uncontrolled blood pressure after at least 4 weeks of treatment with nebivolol or zofenopril calcium monotherapies
    To evaluate the total number and percentage of patients who achieved the blood pressure goal (sitting blood pressure =130/80 mmHg) at Visit 2 and Visit 3
    To assess compliance to the monotherapy and extemporaneous combination (actual doses taken versus doses to be taken)
    To evaluate the safety and tolerability of the zofenopril calcium and nebivolol monotherapies, and the extemporaneous combination of nebivolol 5 mg and zofenopril calcium 30 mg after 8 weeks of treatment
    ¿ Valutare l’effetto antipertensivo della combinazione estemporanea di NEB 5 mg e ZOF 30 mg nel ridurre la PAS in posizione seduta dopo 8 settimane di trattamento in pazienti con PA non controllata, dopo almeno 4 settimane di trattamento con monoterapia NEB o ZOF.
    ¿ Valutare il numero totale e la percentuale di pazienti che hanno raggiunto l’obiettivo di PA (PA in posizione seduta =°130/80 mmHg) alla Visita 2 e alla Visita 3.
    ¿ Valutare la conformità alla monoterapia e all’associazione estemporanea (dosi effettive assunte rispetto alle dosi programmate da prendere).
    ¿ Valutare la sicurezza e la tollerabilità delle monoterapie con ZOF e NEB e la combinazione estemporanea di NEB 5 mg e ZOF 30 mg dopo 8 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female Caucasian uncontrolled hypertensive patients =18 and <65 years of age (see definition in criterion 3), in monotherapy either with ACE-i or BBs since at least 1 month, at Screening.
    2. Patients are able to understand and have freely given written informed consent at Screening.
    3. Patients with mean sitting SBP =140 mmHg and =179 mmHg and/or mean sitting DBP = 90 mmHg and =109 mmHg at Screening.
    4. Patients who are able to comply with all study procedures and who are available for the duration of the study.
    5. Ability to take oral medication and willing to adhere to the drug regimen.
    6. A female patient of childbearing potential is eligible to participate if she is not pregnant, or not breastfeeding. A woman is considered fertile following menarche and until becoming postmenopausal unless permanently sterile. Women of childbearing potential must agree to use of highly effective contraception (eg, method of birth control throughout the study period and for 4 weeks after study completion defined as a method which results in a failure rate of less than 1% per year) and also must refrain from donating or storing eggs during this time. Highly effective contraception methods can be:
    ¿ combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    ¿ progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    ¿ intrauterine device (IUD)
    ¿ intrauterine hormone-releasing system (IUS)
    ¿ bilateral tubal occlusion
    ¿ vasectomized partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success).
    7. A male patient with female partner must agree to use contraception during the whole study period and for at least 1 week after the last dose of study treatment and refrain from donating sperms during this period.
    1. Pazienti caucasici di entrambi i sessi con ipertensione non controllata (vedere definizione nel criterio 3) di età =°18 e <°65 anni, in monoterapia con ACE-I o BB da almeno 1 mese, allo Screening (Visita 1).
    2. I pazienti sono in grado di comprendere e hanno fornito liberamente il proprio consenso informato scritto allo Screening.
    3. Pazienti con PAS media in posizione seduta =°140 mmHg e =°179 mmHg e/o PAD media in posizione seduta =°90 mmHg e =°109 mmHg allo Screening (Visita 1).
    4. Pazienti in grado di attenersi a tutte le procedure dello studio e disponibili per tutta la durata dello studio.
    5. Capacità di assumere farmaci orali e disponibilità ad aderire al regime farmacologico.
    6. Le pazienti di sesso femminile in età fertile sono idonee a partecipare se non sono in gravidanza o non stanno allattando. Una donna è considerata potenzialmente fertile dopo il menarca e fino alla post menopausa, salvo se permanentemente sterile. Le donne in età fertile devono accettare di utilizzare un metodo contraccettivo altamente efficace (ad es., un metodo di controllo delle nascite per l’intero periodo dello studio e per 4 settimane dopo il completamento dello studio, definito come un metodo con un tasso di insuccesso inferiore all’1% annuo) e inoltre devono astenersi dalla donazione o dalla conservazione degli ovuli durante questo periodo. Metodi contraccettivi altamente efficaci possono essere:
    • Contraccezione ormonale combinata (contenente estrogeno e progestinico) associata all’inibizione dell’ovulazione (orale, intravaginale, transdermica)
    • Contraccezione ormonale a base di solo progestinico associata all’inibizione dell’ovulazione (orale, iniettabile, impiantabile)
    • Dispositivo intrauterino (IUD)
    • Sistema intrauterino a rilascio di ormoni (IUS)
    • Occlusione bilaterale delle tube
    • Compagno vasectomizzato (a condizione che il compagno sia l’unico partner sessuale della partecipante alla sperimentazione e che il compagno vasectomizzato si sia sottoposto a una valutazione medica del successo chirurgico)
    7. Un paziente di sesso maschile con compagna di sesso femminile deve accettare di usare un metodo contraccettivo durante l’intero periodo dello studio e per almeno 1 settimana dopo l’ultima dose del trattamento dello studio e astenersi dalla donazione di sperma durante questo periodo.
    E.4Principal exclusion criteria
    1. Known contraindications, allergies, or hypersensitivities to any of the study medications or excipient as outlined in the investigators brochures IBs, summary of product characteristics (SmPCs) or local package inserts for nebivolol and zofenopril calcium.
    2. Patients with serious disorders (in the opinion of the Investigator) which may limit the ability to evaluate the efficacy or safety of the tested medications, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, hematological, or oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.
    3. Patients having a history of the following within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, bypass surgery, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischemic attack.
    4. Patients with secondary hypertension of any etiology such as renal diseases, pheochromocytoma, or Cushing’s syndrome.
    5. Patients with severe heart failure (New York Heart Association classification III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.
    6. Patients with clinical evidence of renal disease as per the Investigator’s judgement (including renovascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary kidney, or severe renal impairment).
    7. History of angioneurotic edema.
    8. Patients with clinically relevant hepatic impairment.
    9. Patients with sick sinus syndrome, including sino-atrial block.
    10. Patients with second- or third-degree heart block (without a pacemaker).
    11. History of bronchospasm and bronchial asthma.
    12. Patients with bradycardia (heart rate <60 bpm).
    13. Patient with metabolic acidosis.
    14. Patients with severe peripheral circulatory disturbances.
    15. Participation in another study within the last 4 weeks.
    16. Patients with diseases that, in the opinion of the Investigator, prevent a careful adherence to the protocol
    17. Pregnant and breastfeeding women. NOTE: a pregnancy test will be performed on all women of childbearing potential at each study visit.
    1. Controindicazioni note, allergie o ipersensibilità a qualsiasi farmaco dello studio o eccipiente, come indicato nelle Investigator Brochure (IB), nel riassunto delle caratteristiche del prodotto (RCP) o nei fogli illustrativi locali di NEB e ZOF.
    2. Pazienti con patologie gravi (a giudizio dello Sperimentatore) che possono limitare la capacità di valutare l’efficacia o la sicurezza dei farmaci testati, tra cui malattie cerebrovascolari, cardiovascolari, renali, respiratorie, epatiche, gastrointestinali, endocrine o metaboliche, ematologiche, oppure oncologiche, neurologiche e psichiatriche. Lo stesso vale per i pazienti immunocompromessi e/o neutropenici.
    3. Pazienti che, negli ultimi 6 mesi, hanno un’anamnesi di: infarto miocardico, angina pectoris instabile, intervento coronarico percutaneo, intervento di bypass, insufficienza cardiaca, encefalopatia ipertensiva, eventi cerebrovascolari (ictus) o attacco ischemico transitorio.
    4. Pazienti con ipertensione secondaria di qualsiasi eziologia, come malattie renali, feocromocitoma o sindrome di Cushing.
    5. Pazienti con insufficienza cardiaca grave (classe III-IV secondo la New York Heart Association), restringimento della valvola aortica o bicuspide, ostruzione del deflusso cardiaco (cardiomiopatia ostruttiva, ipertrofica) o coronaropatia sintomatica.
    6. Pazienti con evidenza clinica di malattia renale in base al giudizio dello Sperimentatore (tra cui malattia occlusiva renovascolare, nefrectomia e/o trapianto renale, stenosi bilaterale dell’arteria renale o stenosi unilaterale dell’arteria renale in un unico rene, o grave insufficienza renale).
    7. Anamnesi di edema angioneurotico.
    8. Pazienti con insufficienza epatica clinicamente rilevante.
    9. Pazienti con sindrome del nodo del seno, incluso blocco seno atriale.
    10. Pazienti con blocco cardiaco di secondo o terzo grado (senza pacemaker).
    11. Anamnesi di broncospasmo e asma bronchiale.
    12. Pazienti con bradicardia (frequenza cardiaca <°60 bpm).
    13. Paziente con acidosi metabolica.
    14. Pazienti con gravi disturbi circolatori periferici.
    15. Partecipazione a un altro studio nelle ultime 4 settimane.
    16. Pazienti affetti da malattie che, a giudizio dello Sperimentatore, impediscono un’attenta aderenza al protocollo.
    17. Donne in gravidanza e in allattamento. NOTA: a ogni visita dello studio, sarà eseguito un test di gravidanza su tutte le donne potenzialmente fertili.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean sitting DBP between Week 0 (Visit 2) and Week 8 (Visit 3)
    ¿ Variazione della PAD media in posizione seduta tra la Settimana 0 (Visita 2) e la Settimana 8 (Visita 3).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 and Week 8
    Week 0 and Week 8
    E.5.2Secondary end point(s)
    ¿ Change in mean sitting SBP between Week 0 (Visit 2) and Week 8 (Visit 3)
    ¿ Total number and proportion of patients achieving the BP goal (sitting BP =130/80 mmHg) at Week 0 (Visit 2) and Week 8 (Visit 3)
    ¿ Adherence to treatment will be measured through treatment compliance which is 100 × (actual doses taken versus planned doses to be taken) from Visit 1 to Visit 2 for the monotherapies, and from Visit 2 to Visit 3 for the extemporaneous combination
    ¿ Safety and tolerability of the nebivolol and zofenopril calcium monotherapies, as well as extemporaneous combination between nebivolol 5 mg and zofenopril calcium 30 mg will be measured by Adverse Events (AEs),Serious Adverse Events (SAEs),Adverse Events Of Special Interest (AEOSI), vital signs, physical examination, ECG, and concomitant medications at Week 0 (Visit 2) and Week 8 (Visit 3)
    ¿ Variazione della PAS media in posizione seduta tra la settimana 0 (Visita 2) e la settimana 8 (Visita 3).
    ¿ Numero totale e percentuale di pazienti che raggiungono l’obiettivo di PA (PA in posizione seduta =°130/80 mmHg) alla settimana 0 (Visita 2) e alla settimana 8 (Visita 3).
    ¿ L’aderenza al trattamento sarà misurata con un valore di conformità al trattamento pari a 100 × (dosi effettive assunte rispetto alle dosi programmate da assumere) dalla Visita 1 alla Visita 2 per le monoterapie e dalla Visita 2 alla Visita 3 per l'associazione estemporanea.
    ¿ La sicurezza e la tollerabilità delle monoterapie NEB e ZOF, nonché l’associazione estemporanea di NEB 5 mg e ZOF 30 mg, saranno misurate in base a eventi avversi (EA), eventi avversi seri (SAE), EA di particolare interesse (AESI), segni vitali, esame obiettivo, elettrocardiogramma (ECG) e farmaci concomitanti alla Settimana 0 (Visita 2) e alla Settimana 8 (Visita 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0 and Week 8
    Week 0 and Week 8
    Week 0 and Week 8
    Week 0 and Week 8
    Week 0 and Week 8
    Week 0 and Week 8
    Week 0 and Week 8
    Week 0 and Week 8
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Periodo di run-in con neb o zof come monoterapia + periodo di valutazione con combinazione neb/zof
    Run in period with neb or zof as monotherapy + assessment period with neb/zof combination
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA 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
    Last Patient Last Visit
    Last Patient Last Visit
    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 months8
    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 months8
    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: 216
    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 216
    F.4.2.2In the whole clinical trial 216
    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)
    Standard of care as per local practice
    Standard of care per pratica locale
    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 Decision2021-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA