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    Summary
    EudraCT Number:2009-018173-31
    Sponsor's Protocol Code Number:POISE-2Trial
    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:2010-02-15
    Trial 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 number2009-018173-31
    A.3Full title of the trial
    A large, international, placebo-controlled, factorial trial to assess the impact of clonidine and acetyl-salicylic acid (ASA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.
    Studio prospettico,randomizzato multicentrico, internazionale, farmacologico vs placebo, volto a valutare l'impatto della clonidina e dell'acido acetilsalicilico (ASA) in pazienti sottoposti a chirurgia non cardiaca a rischio per eventi cardiovascolari nel perioperatorio.
    A.4.1Sponsor's protocol code numberPOISE-2Trial
    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 SponsorPOPULATION HEART RESEARCH INSTITUTE (PHRI)
    B.1.3.4CountryCanada
    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 supportnessun finanziamento
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione San Raffaele del Monte Tabor
    B.5.2Functional name of contact pointAnest. e Rianim. Cardiotoracovasc.
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina,60
    B.5.3.2Town/ citymilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02.26437176
    B.5.5Fax number02.26437178
    B.5.6E-maillandoni.giovanni@hsr.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 ASPIRINA
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SpA
    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.3.4Pharmaceutical 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 INNSalicylic acid and derivatives
    D.3.9.1CAS number 50-78-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.3.11.13.1Other medicinal product typedi natura chimica
    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 CATAPRESAN*30CPR 150MCG
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM IT.SpA
    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.3.4Pharmaceutical 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 INNClonidine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typefarmaco di natura chimica
    D.IMP: 3
    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 catapres-TTS
    D.2.1.1.2Name of the Marketing Authorisation holderALZA COORPORATION
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClonidine
    D.3.9.1CAS number 4205-90-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typefarmaco di natura chimica
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    patients affected by coronary disease undergoing non cardiac surgery
    pazienti affetti o a rischio di coronaropatia sottoposti ad intervento di chirurgia non cardiaca
    E.1.1.1Medical condition in easily understood language
    patients affected by coronary disease
    pazienti affetti o a rischio di coronaropatia
    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 HLGT
    E.1.2Classification code 10011082
    E.1.2Term Coronary artery disorders
    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
    To determine the impact of clonidine versus placebo and ASA versus placebo on the 30-day risk of all-cause mortality or nonfatal MI in patients with, or at risk of, atherosclerosic disease who are undergoing noncardiac surgery.
    valutare l` efficacia perioperatoria di farmaci noti, poco costosi e utilizzati a basso dosaggio (acido acetilsalicilico ASA- e clonidina) sulla mortalita` e sull incidenza di infarto miocardico non fatale a 30 giorni in pazienti affetti o a rischio di coronaropatia sottoposti a intervento di chirurgia non cardiaca
    E.2.2Secondary objectives of the trial
    To determine the impact of perioperative administration of low-dose clonidine and separately low-dose ASA on each of the following individual secondary outcomes at 30 days after randomization: all-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis. 2. To determine the impact of perioperative administration of low-dose clonidine and separately low-dose ASA on the composite of all-cause mortality, nonfatal MI, and nonfatal stroke at 30 days after randomization. 3. To determine in each ASA stratum the impact on a composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis
    1.det. l`impatto della sommin perioperatoria della clonidina a basso dosaggio e separatamente ASA a basso dosaggio per ciascuno dei seguenti risultati individuali sec.o a 30 gg dopo la randomizzazione:mortalità per qualsiasi causa,mortalità vascolare,infarto miocardico,arresto cardiaco non fatale,procedure di rivascolarizzazione cardiaca,embolia polmonare,trombosi venosa profonda,clinicamente importanti fibrillazione atriale,riospedalizzazione per motivi vascolare,durata della degenza ospedaliera,durata della terapia intensiva/unità di assistenza cardiaca(ICU/CCU),soggiorno,e nuova insufficienza renale acuta che richieda la dialisi.2.det. l`impatto della sommin perioperatoria della clonidina a basso dosaggio e separatamente ASA a basso dosaggio su un risultato composto di mortalità generale,infarto miocardico non fatale e ictus non fatale a 30 gg dopo la randomizzazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible if: 1. are aged >= 45 years old 2. are expected to require at least an overnight hospital admission after surgery; AND 3. fulfill one or more of the following 5 criteria history of : A. coronary artery disease; B. peripheral vascular disease; C. stroke; D. undergoing major vascular surgery; OR E. any 3 of the following 9 criteria: undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal, or major orthopedic surgery), history of congestive heart failure, transient ischemic attack, diabetes and currently taking an oral hypoglycemic agent or insulin, age > 70 years, hypertension, serum creatinine > 175 ╬╝mol/L (>2.0 mg/dl), history of smoking, within 2 years of surgery, undergoing urgent/emergent surgery.
    pazienti di eta` superiore ai 45 anni; pazienti che richiedano almeno una notte di ricovero post intervento chirurgico e che soddisfino uno o piu` dei seguenti 6 requisiti: storia di patologia coronarica arteriosa; storia di patologie vascolari periferiche; storia di infarto; effettuazione di interventi chirurgici vascolari importanti; precedente rivascolarizzazione coronarica arteriosa; oppure che soddisfino almeno 3 dei seguenti 9 requisiti: -chirurgia maggiore , storia di scompenso cardiaco congestizio,retroperitoneale, attacco ischemico transiente,diabete ed assunzione corrente di terapia ipoglicemizzante od insulina,eta` &gt; o pari a 70 anni,ipertensione,creatinina serica &gt; 175micromol/L, abitudine al fumo entro 2 anni dall`intervento,necessita` di chirurgia d`urgenza
    E.4Principal exclusion criteria
    1. consumption of ASA within 72 hours prior to surgery; 2. hypersensitivity or known allergy to ASA or clonidine; 3. systolic blood pressure < 105 mm Hg; 4. heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker; 5. second or third degree heart block without a permanent pacemaker; 6. active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks; 7. intracranial hemorrhage (including subdural hematoma and parenchymal hematoma as a complication of primary ischemic stroke) documented by neuro-imaging, in the 6 months prior to randomization. This does not include petechial hemorrhagic transformation of a primary ischemic stroke; 8. subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired; 9. drug-eluting coronary stent in the year prior to randomization;96 10. bare-metal coronary stent in the 6 weeks prior to randomization;96 11. thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel)or ticagrelor within 72 hours prior to surgery ; or intention to restart a thienopyridine or ticagrelor during the first 7 days post op; 12. planned use during the first 3 days after surgery therapeutic dose anticoagulation (e.g., warfarin with a target INR > 2.0, dabigatran > 250 mg/day, or rivaroxaban > 10 mg/day) or a therapeutic subcutaneous or intravenous antithrombotic agent (defined as full dose unfractionated heparin [i.e., > 15, 000 u/24hrs], low molecular weight heparin [i.e., > 6,000 u/24hrs or enoxaparin: > 60 mg/24hrs], or fondaparinux [i.e., > 2.5mg/24hrs]; 13. undergoing intracranial surgery, carotid endarterectomy, or retinal surgery; 14. not consenting to participate in POISE-2 prior to surgery; OR 15. previously enrolled in POISE-2 Trial
    1.consumo di ASA entro 72 ore prima dell`intervento; 2. ipersensibilita` o allergia ad ASA o clonidina; 3. pressione sistolica &lt;105 mmHg; 4. frequenza cardiaca &lt;55 battiti al minuto in un paziente che non dispone di un pacemaker permanente; 5. secondo o terzo grado di blocco cardiaco senza un pacemaker permanente; 6. ulcera peptica attiva o sanguinamento gastrointestinale entro sei settimane precedenti; 7. emorragia intracranica (compresi ematoma subdurale ed ematoma parenchimale come complicanza di ictus ischemico primario), documentata da neuro-imaging, nei 6 mesi prima della randomizzazione. Questo non include petecchiali trasformazioni emorragiche di un ictus ischemico primario; 8. emorragia subaracnoidea o ematoma epidurale a meno che l`evento si sia verificato piu` di 6 mesi prima della randomizzazione e l`aneurisma o lesione arteriosa sia stato riparato; 9. stent a eluizione di farmaco coronarico durante l`anno prima della randomizzazione; 96 10. bare-metal stent coronarico nelle 6 settimane prima della randomizzazione; 96 11. 1-tienopiridine (ad esempio, il clopidogrel, ticlopidina, prasugrel)o ticagrelor entro 72 ore prima dell`operazione o intenzione di ripristinare la terapia con thionepyridina o tiragrelor durante i primi 7 gg post operazione; 12. previsto utilizzo - durante i primi 3 giorni dopo l`intervento - di terapia anticoagulante (ad esempio, warfarin con un target INR&gt; 2,0, dabigatran&gt; 250 mg / die, o rivaroxaban&gt; 10 mg / die) o di un agente terapeutico per via sottocutanea o endovenosa antitrombotici (definito come eparina non frazionata a dosaggio pieno [ie,&gt; 15, 000 u/24hrs], cioe` l`eparina a basso peso molecolare del peso [,&gt; 6.000 u/24hrs o enoxaparina:&gt; 60 mg/24hrs], o fondaparinux [cioe`, 2.5mg/24hrs&gt;] ; 13. pazienti sottoposti a chirurgia intracranica, endoarteriectomia carotidea, o a chirurgia retinica; 14. pazienti che non acconsentono di partecipare a POISE-2 prima della chirurgia 15. pazienti precedentemente arruolati in POISE-2 Trial
    E.5 End points
    E.5.1Primary end point(s)
    To determine the impact of clonidine versus placebo and ASA versus placebo on the 30-day risk of all-cause mortality or nonfatal MI in patients with, or at risk of, atherosclerosic disease who are undergoing noncardiac surgery.
    valutare l efficacia perioperatoria di farmaci noti, poco costosi e utilizzati a basso dosaggio (acido acetilsalicilico ASA- e clonidina) sulla mortalita' e sull incidenza di infarto miocardico non fatale a 30 giorni in pazienti affetti o a rischio di coronaropatia sottoposti a intervento di chirurgia non cardiaca
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days from randomization
    30 giorni dalla randomizzazione
    E.5.2Secondary end point(s)
    the composite of all-cause mortality, nonfatal MI, and nonfatal stroke at 30 days after randomization
    l`insieme delle cause di mortalita`, Mi non fatale, ed infarto non fatale a 30 gg dopo la randomizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after randomization
    30 giorni dopo la randomizzazione
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA101
    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
    Canada
    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
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pzianti che si sottopongono a chirurgia non cardiaca ceh soddisfino i criteri di inclusione
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 10000
    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 Decision2010-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-17
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