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    Summary
    EudraCT Number:2005-003351-12
    Sponsor's Protocol Code Number:A6141079
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-01-19
    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 number2005-003351-12
    A.3Full title of the trial
    THE EFFECT OF EPLERENONE VERSUS PLACEBO ON CARDIOVASCULAR MORTALITY AND HEART FAILURE HOSPITALIZATION IN SUBJECTS WITH NYHA CLASS II CHRONIC SYSTOLIC HEART FAILURE
    L EFFETTO DELL EPLERENONE VERSO PLACEBO SULLA MORTALITA CARDIOVASCOLARE E IL RICOVERO PER SCOMPENSO CARDIACO IN PAZIENTI CON INSUFFICIENZA CARDIACA SISTOLICA CRONICA DI CLASSE II NYHA
    A.4.1Sponsor's protocol code numberA6141079
    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 SponsorPFIZER
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameInspra
    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 INNEplerenone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic systolic heart failure
    Insufficienza cardiaca sistolica cronica
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007558
    E.1.2Term Cardiac failure chronic
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the efficacy and safety of eplerenone plus standard heart failure (HF) therapy versus placebo plus standard HF therapy on the cumulative incidence of cardiovascular (CV) mortality or HF hospitalization (a composite primary endpoint).
    L obiettivo primario di questa sperimentazione e` di valutare l efficacia e la sicurezza dell Eplerenone aggiunto alla terapia standard prevista per il trattamento dello scompenso cardiaco (HF) verso placebo aggiunto alle terapie standard dello scompenso cardiaco, sulla incidenza comulativa di mortalita` cardiovascolare e l ospedalizzazione per scompenso cardiaco (endpoint primario composito).
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained prior to the initiation of any study procedures; 2. Male or female subjects, >/=55 years of age at the time informed consent is obtained; 3. Chronic systolic heart failure (HF) of either ischemic or non-ischemic etiology. a. Duration: at least 4 weeks; b. Left ventricular ejection fraction (LVEF): </=30% by echocardiography, contrast ventriculography, magnetic resonance imaging or nuclear imaging, based on local clinical practice. The most recent measurement within 6 months prior to randomization must be used. OR Left ventricular ejection fraction (LVEF) </=35% in addition to QRS duration >/=130 msec. It is mandatory that subjects with LVEF 31-35% must also have QRS duration >/=130 msec to be eligible for this trial. c. Functional Capacity: Currently NYHA II (in the investigator s opinion); d. Treatments (for ACE inhibitors, ARBs and b-blockers, optimal target or maximal tolerated dose [See Appendix 1 Optimal Target Doses of Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARBs) and b-Blockers] unless contraindicated). - Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs); - b-blocker; - Diuretic, if clinically indicated to reduce fluid retention; 4. Serum potassium (K+) level </= 5.0mmol/L within 24 hours prior to randomization. 5. Estimated glomerular filtration rate (eGFR) >7=30 ml/min/1.73m2 within 24 hours prior to randomization (See Appendix 2 Calculation of Estimated Glomerular Filtration Rate (eGFR)). 6. Randomization must occur no later than 6 months from the date of admission to hospital for a cardiovascular reason (see definition of cardiovascular hospitalization below). If the subject is clinically stable, he or she may be randomized during admission for a cardiovascular reason. OR In the absence of a recent admission to hospital for a cardiovascular reason, documentation of a plasma concentration of B-type natriuretic peptide (BNP) of at least 250 pg/ml or amino-terminal proB-type natriuretic peptide (NT-proBNP) of at least 500 pg/ml for males and 750 pg/ml for females, within 15 days of randomization. 7. If the subject is a female, the following should apply. a. Have a negative serum pregnancy within 72 hours prior to the first dose of study drug, except if she previously had a total hysterectomy or is >65 years old; b. Agree to use an adequate form of contraception (Abstinence will not be considered an acceptable form of contraception) if she is of child-bearing potential. 8. Subjects previously treated with an aldosterone antagonist for >7 consecutive days will be allowed if they fulfill the following criteria: a. No history of clinically significant hyperkalemia or renal impairment during earlier use of an aldosterone antagonist; b. The aldosterone antagonist must have been discontinued for at least 3 months prior to randomization. A washout period of 48 hours is deemed adequate for subjects treated with an aldosterone antagonist for less than or equal to7 days. Subjects who have a bona fide need for an aldosterone antagonist must not be discontinued from treatment just to make them eligible for entry into this trial. 9. Subjects in whom the primary cause of heart failure is inoperable valve disease.
    1. Il consenso informato scritto deve essere ottenuto prima dell avvio delle precedure dello studio 2. Pazienti di sesso maschile e/o femminile, di eta` &gt;/= 55 anni al momento dell ottenimento del consenso informato 3. Insufficienza cardiaca cronica sistolica di eziologia ischemica o non ischemica: Durata: almeno 4 settimane Frazione di eiezione ventricolare sinistra (LVEF): &lt;/= 30% in base all ecocardiografia, ventricolografia con mezzo di contrasto, risonanza magnetica imaging o imaging nucleare, in base della pratica clinica locale.Dovra` essere utilizzata la piu` recente misurazione effettuata entro i 6 mesi prima della randomizzazione. O Frazione di eiezione ventricolare sinistra (LVEF) &lt;/=35% in aggiunta alla durata del QRS&gt;/= 130 msec. E` obbligatorio che i soggetti con LVEF 31-35% debbano avere anche la durata QRS&gt;/= 130 msec per essere elegibili in questo studio. c. Capacita` funzionale: classe NYHA II ( secondo l opinione dell Investigatore) d.Trattamenti: ACE-inibitori e/o bloccanti dei ricettori dell angiotensina (ARB), dose ottimale o dose tollerata (vedi Appendix 1) , a meno che controindicati . - b-bloccanti - diuretici, se clinicamente indicati per la riduzione della ritenzione idrica. 4. Potassiemia &lt;/= 5.0 mmol/L entro le 24 ore prima della randomizzazione. 5. tasso stimato di filtrazione glomerulare (eGFR) &gt;/=30 ml/min/1.73m2 entro le 24 ore prima della randomizzazione. (Appendice 2) 6. La randomizzazione deve avvenire entro 6 mesi dalla data di ospedalizzazione per problemi cardiovascolari. ( Se clinicamente stabile, il paziente potra` essere randomizzato durante questa ospedalizzazione dovuta a problemi cardiovascolari (CV) o, In assenza di un recente ricovero in ospedale per motivi cardiovascolari , documentazione di una concentrazione plasmatica di tipo B-natriuretic peptide (BNP) di almeno 250 pg / ml o ammino-terminale di tipo pro-natriuretic peptide (NT-proBNP) di almeno 500 pg / ml per i maschi e 750 pg / ml per le donne, entro 15 giorni dalla randomizzazione. 7. Se la paziente e` una donna in eta` fertile: a) Deve avere un test sierico di gravidanza che sia negativo entro le 72 ore precedenti alla prima dose programmata di farmaco in studio, tranne il caso abbia avuto in precedenza una totale isterectomia abbia eta` &gt;65 anni; b)Fare uso di un adeguato metodo contraccettivo (l astinenza non viene considerata un metodo di contraccezione efficace). 8. Soggetti trattati in precedenza con un antagonista aldosterone per&gt; 7 giorni consecutici se soddisfano i seguenti criteri: a. nessuna storio clinicamente significativa di insufficienza renale o iperkalemia durante un precedente uso di un antagonista di aldosterone; b. L`antagonista aldosterone deve essere stato sospeso per un periodo di almeno 3 mesi prima della randomizzazione. Un periodo di washout di 48 ore e` considerato adeguato per i soggetti trattati con uno di aldosterone antagonista per &gt;/= 7giorni. 9. Soggetti nei quali la principale causa di insufficienza cardiaca e` dovuta alla malattia della valvola inutilizzabile
    E.4Principal exclusion criteria
    1.Patients with severe chronic systolic heart failure, defined as patients who demonstrate symptoms usually at rest despite optimal medical therapy. 2.Patients with a myocardial infarction complicated by left ventricular systolic dysfunction and clinical heart failure within 30 days prior to randomization. 3.Patients with stroke within 30 days prior to randomization. 4.Patients who have had cardiac surgery within 30 days prior to randomization. 5.Patients who have had percutaneous coronary intervention (PCI) within 30 days prior to randomization. 6.Patients previously exposed to treatment with an aldosterone antagonist for >7 consecutive days, in whom the aldosterone antagonist has not been discontinued permanently for at least 3 months prior to randomization, or patients who have a history of clinically significant hyperkalemia or renal impairment during a previous exposure to an aldosterone antagonist. 7.Patients who require treatment with eplerenone, spironolactone or potassium canrenoate and either have prior NYHA class IV heart failure associated with a LVEF </=0.35 (as in the RALES trial) [2] or heart failure or diabetes and a LVEF <0.40 after acute MI (as in EPHESUS trial).8.Patients with uncontrolled hypertension, defined as having a systolic blood pressure >180 mmHg and/or a diastolic blood pressure >110 mmHg. 9.Patients with symptomatic hypotension or having a systolic blood pressure <85 mmHg. 10.Patients, who in the opinion of the investigator, require treatment with potassium-sparing diuretics. 11.History of hypersensitivity to eplerenone or spironolactone. 12.Evidence of cardiogenic shock. 13.Patients in whom the primary cause of heart failure is surgically amenable valve disease, pericardial disease or an obstructive or restrictive cardiomyopathy. 14.Intra-aortic balloon pump or other mechanical assist device. 15.Patients awaiting cardiac transplantation. 16.Serum potassium >5.0 mmol/L within 24 hours prior to randomization. 17.Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 within 24 hours prior to randomization (See Appendix 2 Calculation of Estimated Glomerular Filtration Rate (eGFR)). 18.Concomitant use of potent cytochrome p450 3A4 (CYP3A4) inhibitors, such as but not limited to: a.Ketoconazole; b.Itraconazole; c.Nefazodone; d.Troleandomycin; e.Clarithromycin; f.Ritonavir; g.Nelfinavir. 19.Concomitant use of cytochrome p450 3A4 (CYP3A4) inducers, such as but not limited to: a.St.John s Wort; b.Rifampin; c.Carbamazepine; d.Phenytoin; e.Phenobarbitol. 20.Hemoglobin <10g/dL. 21.Patients with preexisting significant hepatic disease (for example, known positive serology for viral hepatitis) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 times the upper limits of normal. 22.Patients status-post gastric bypass surgery, partial gastrectomy or other surgery of the gastrointestinal tract that may interfere with the absorption of eplerenone. 23.Patients with preexisting serious conditions (eg, cancer, Acquired Immunodeficiency Syndrome (AIDS).Patients with a previous history of cancer will be eligible if in the opinion of the investigator life expectancy is anticipated to be greater than 5 years. 24.Patients unable to give written informed consent. 25.Patients with a progressively fatal disease (except congestive heart failure) and/or life expectancy less than 3 years. 26.Patients receiving immunosuppressive or antineoplastic therapy. 27.Patients with a history of alcohol and/or any other drug abuse that in the opinion of the investigator will make the patient unreliable. 28.Patients who previously participated in this trial. 29.Patients who are likely to require treatment during the trial period with drugs not permitted by this protocol.
    1.Pazienti con scompenso cardiaco sistolico cronico di grado severo, definiti come pazienti che mostrano sintomi generalmente a riposo, nonostante una terapia medica ottimale. 2.Pazienti con infarto miocardico acuto complicato da disfunzione sistolica ventricolare sinistra e scompenso cardiaco clinico, entro 30 giorni prima dalla randomizzazione. 3.Pazienti con ictus entro 30 giorni prima della randomizzazione. 4.Pazienti sottoposti ad intervento di cardiochirurgia, entro 30 giorni prima della randomizzazione. 5.I pazienti che hanno avuto un intervento coronarico percutaneo (PCI) entro 30 giorni prima alla randomizzazione. 6.I pazienti precedentemente esposti a trattamento con un antagonista di aldosterone&gt; 7 giorni consecutivi, in cui l`aldosterone antagonista non e` stato interrotto permanentamente per almeno 3 mesi prima della randomizzazione, o pazienti che hanno una storia clinicamente significativa di insufficienza renale o iperkalemia durante una precedente esposizione ad un antagonista di aldosterone. 7.Pazienti che necessitano di trattamento con eplerenone, spironolattone o di potassio canrenoate e abbiano o IV NYHA scompenso cardiaco di prima classe associato ad un LVEF &lt;/=0,35 o scompenso cardiaco o il diabete e una LVEF &lt;0,40 dopo acuta MI 8.Pazienti con ipertensione non controllata, definit come pressione arteriosa sistolica &gt; 180 mmHg e / o un pressione diastolica&gt; 110 mmHg. 9.Pazienti con ipotensione sintomatica o con una pressione arteriosa sistolica &lt;85 mmHg 10.Pazienti che, secondo la valutazione dello sperimentatore, necessitano di trattamento con diuretici risparmiatori di potassio o di supplemento di potassio nella dieta. 11.Storia di ipersensibilita` all eplerenone o allo spironolattone. 12.Evidenze di Shock cardiogenico 13.Pazienti in cui la causa principale di insufficienza cardiaca e` malattia della valvola sensiile a chirurgia, o di una malattia pericardica o cardiomiopatia ostruttiva o restrittiva 14.Pompa a pallone Intra-aortica o altro ausilio meccanico 15.Pazienti in attesa di un trapianto cardiaco 16.Potassiemia &gt; 5.0 mmol/L nelle 24 ore precedenti alla randomizzazione 17.Tasso di filtrazione glomerulare stimato (eGFR) &lt;30 ml/min/1.73m2 entro le 24 ore prima della randomizzazione 18.Uso concomitante di forti inibitori CYP3A4, come i seguenti, ma non solo: a)Chetoconazolo; b)Itraconazolo; c)Nefazodone; d)Troleandomicina; e)Claritromicina; f)Ritonavir; g Nelfinavir 19.Uso concomitante degli induttori del citocromo p-450 3A4 (CYP3A4)come i seguenti, ma non solo:Wort St.John, Rifampina, Carbamazepina, Fenitoina, Fenobarbitolo 20.Emoglobina &lt;10g/dL 21.Pazienti con patologie epatiche significative, definiti come segue: a) Aspartato aminotransferasi (AST) &gt; tre volte il limite normale massimo E/O b) Alanina aminotransferasi (ALT) &gt; tre volte il limite normale massimo E/O c) Sierologia positiva conosciuta per epatite virale 22.Pazienti che hanno subito un intervento di by-pass gastrico, di gastrectomia parziale o altri interventi del tratto gastrointestinale che possano interferire con l assorbimento dell eplerenone 23.Pazienti con diagnosi conosciuta di Sindrome da Immunodeficienza Acquisita (AIDS).pazienti con storia di tumore possono sono elegibile se a giudizio dello sperimentatore hanno una aspettativa di vita &lt;5anni. 24.Pazienti incapaci di dare il proprio consenso 25.Pazienti con patologie progressive fatali e/o aspettativa di vita inferiore ai 3 anni 26.Pazienti che ricevono una terapia immunosoppressiva o chemioterapia antiblastica 27.Pazienti con precedenti di alcolismo o di abuso di droghe 28.Pazienti che hanno precedentemente partecipato a questa sperimentazione o a qualunque altra sperimentazione clinica col farmaco in studio 29.Pazienti che possono richiedere durante lo studio farmaci non permessi.
    E.5 End points
    E.5.1Primary end point(s)
    Primary The primary efficacy endpoint is the first occurrence of cardiovascular (CV) mortality or heart failure (HF) hospitalization (following randomization);
    L endpoint primario di efficacia e` il primo evento che si manifesta di mortalita` cardiovascolare o ricovero dovuto a scompenso cardiaco dopo la randomizzazione
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Therapia standard
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA172
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number 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) No
    F.1.3Elderly (>=65 years) Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1718
    F.4.2.2In the whole clinical trial 3102
    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 Decision2006-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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