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    Summary
    EudraCT Number:2012-002333-11
    Sponsor's Protocol Code Number:R727-CL-1118
    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:2013-01-11
    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 number2012-002333-11
    A.3Full title of the trial
    A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin.
    Studio clinico randomizzato in doppio cieco sull'efficacia e la sicurezza di REGN727 in associazione a rosuvastatina rispetto alla terapia di associazione con ezetimibe e rosuvastatina e all'aumento del dosaggio di rosuvastatina in pazienti non controllati con rosuvastatina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficay and Safety of REGN727 added-on to Rosuvastatin versus Ezetimibe added-on to Rosuvastatin versus Rosuvastatin dose increase in patients who are not controlled on Rosuvastatin.
    Efficacia e sicurezza di REGN727 in associazione a rosuvastatina rispetto alla terapia di associazione con ezetimibe e rosuvastatina e all’aumento del dosaggio di rosuvastatina in pazienti non controllati con rosuvastatina
    A.3.2Name or abbreviated title of the trial where available
    Odissey Options II
    Odissey Options II
    A.4.1Sponsor's protocol code numberR727-CL-1118
    A.5.4Other Identifiers
    Name:IND NumberNumber:105574
    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 SponsorREGENERON PHARMACEUTICALS, INC.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointStephen Donahue, MD
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 914 847 5672
    B.5.6E-mailstephen.donahue@regeneron.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 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 nameREGN727/SAR236553
    D.3.2Product code REGN727
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGN 727
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeREGN727 (SAR236553)
    D.3.9.3Other descriptive nameREGN727 (SAR236553)
    D.3.9.4EV Substance CodeSUB74847
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 RoleComparator
    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 CRESTOR
    D.2.1.1.2Name of the Marketing Authorisation holderASTRA ZENECA
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule
    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 INNROSUVASTATIN CALCIUM
    D.3.9.1CAS number 147098-20-2
    D.3.9.2Current sponsor codeRosuvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Ezetrol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule
    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 INNEZETIMIBE
    D.3.9.1CAS number 163222-33-1
    D.3.9.2Current sponsor codeEZE
    D.3.9.4EV Substance CodeSUB16430MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Patient with Non-familial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH)at high CV risk who are not adequately controlled with rosuvastatin (10 mg or 20 mg) with or without other lipid-modifying therapy (LMT) (excluding EZE).
    Pazienti con ipercolesterolemia non familiare (FH) o ipercolesterolemia familiare eterozigote (heFH) ad alto rischio CV che non sono adeguatamente controllati con rosuvastatina (10 mg o 20 mg) con o senza altra terapia modificante dei lipidi (LMT) (escluso EZE).
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol level.
    Alti livelli di colesterolo nel sangue.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020603
    E.1.2Term Hypercholesterolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the reduction of LDL-C by REGN727 as add-on therapy to rosuvastatin in comparison with EZE as add-on therapy to rosuvastatin, and in comparison with doubling the rosuvastatin dose, after 24 weeks of treatment in patients with hypercholesterolemia at high CV risk.
    Valutare la riduzione del C-LDL da parte di REGN727 come terapia di associazione con rosuvastatina in confronto con EZE come terapia di associazione con rosuvastatina, e in confronto con il raddoppio della dose di rosuvastatina, dopo 24 settimane di trattamento nei pazienti con alto rischio CV.
    E.2.2Secondary objectives of the trial
    -To evaluate the reduction of LDL-C by REGN727 75 mg as add-on therapy to rosuvastatin in comparison with EZE as add-on therapy to rosuvastatin, or in comparison with doubling of the rosuvastatin dose after 12 weeks of treatment -To evaluate the effect of REGN727 on other lipid parameters (eg,ApoB,non-HDL-C,total-C,Lp[a]),HDL-C,TG levels,ApoA-1) -To evaluate the safety and tolerability of REGN727 -To evaluate the development of anti-REGN727 antibodies
    -Valutare la riduzione di C-LDL da parte di REGN727 75 mg come terapia di associazione con rosuvastatina rispetto a EZE come terapia di associazione con rosuvastatina, o in confronto con il raddoppio della dose di rosuvastatina dopo 12 settimane di trattamento -Valutare l'effetto di REGN727 su altri parametri dei lipidi (ovvero,ApoB,colesterolo non-HDL-C,colesterolo totale, Lp[a]),C-HDL, livelli dei TG,ApoA-1) -Valutare la sicurezza e la tollerabilità di REGN727 -Valutare lo sviluppo di anticorpi anti-REGN727
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC:
    Vers:1
    Date:2012/06/26
    Title:A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin
    Objectives:To identify genetic associations with clinical or biomarker response to PCSK9 inhibition, hyperlipidemia, or CVD. If needed, samples may also be used to identify markers associated with toxicity.

    FARMACOGENOMICA:
    Vers:1
    Data:2012/06/26
    Titolo:Studio clinico randomizzato in doppio cieco sull'efficacia e la sicurezza di REGN727 in associazione a rosuvastatina rispetto alla terapia di associazione con ezetimibe e rosuvastatina e all’aumento del dosaggio di rosuvastatina in pazienti non controllati con rosuvastatina
    Obiettivi:Identificare le associazioni genetiche con risposta clinica o a livello di biomarker da inibizione di PCSK9, iperlipidemia, o CVD. Se necessario, i campioni possono anche essere utilizzati per identificare marcatori associati a tossicità.

    E.3Principal inclusion criteria
    A patient must meet either 1a or 1b to be eligible for inclusion in the study: a. Patients with screening (visit 1) LDL-C ≥70 mg/dL (1.81 mmol/L) who are not adequately controlled with a 10 mg or 20 mg stable daily dose of rosuvastatin for at least 4 weeks before the screening visit (visit 1), with or without other LMT, excluding EZE. Patients with heFH* or non-FH must also have a history of documented CHD (defined below), or non-CHD CVD (defined below) or diabetes mellitus with target organ damage. OR b. Patients with screening (visit 1) LDL-C ≥100 mg/dL (2.59 mmol/L) who are not adequately controlled with a 10 mg or 20 mg stable daily dose of rosuvastatin for at least 4 weeks before the screening visit (visit 1), with or without other LMT (excluding EZE). Patients must also have heFH*, or have non-FH, without CHD or non-CHD CVD, but with a calculated 10-year fatal CVD risk SCORE ≥5%, or with moderate CKD, or with diabetes mellitus but no target organ damage.
    Un paziente deve soddisfare sia 1a o 1b per essere eleggibile per l'inclusione nello studio: a. I pazienti con screening (visita 1) C-LDL ≥ 70 mg / dL (1,81 mmol / L) che non sono adeguatamente controllati con una dose stabile di 10 mg o 20 mg al giorno di rosuvastatina per almeno 4 settimane prima della visita di screening (visita 1 ), con o senza altre LMT, escluso EZE. I pazienti con heFH o non-FH devono anche avere una storia di malattia coronarica documentata (definito di seguito), o non-CHD CVD (definito di seguito) o diabete mellito con danno d'organo. O b. I pazienti con screening (visita 1) C-LDL ≥ 100 mg / dL (2,59 mmol / L) che non sono adeguatamente controllati con una dose stabile di 10 mg o 20 mg al giorno di rosuvastatina per almeno 4 settimane prima della visita di screening (visita 1 ), con o senza altre LMT (escluso EZE). I pazienti devono anche avere heFH, o non-FH, senza CHD o non CHD CVD, ma con un rischio di CVD fatale ≥5% calcolato in 10 anni, o con CKD moderata, o con diabete mellito, ma non danno all'organo bersaglio .
    E.4Principal exclusion criteria
    LDL-C <70mg/dL (<1.81mmol/L) in patients with CVD;LDL-C <100mg/dL (<2.59mmol/L) in patients without CVD,but with other risk factor;LDL-C >250mg/dL or TG >400mg/dL;Homozygous FH or patients receiving plasmapheresis CV event within 3 months prior to screening;NYHA Class III or IV heart failure;History of hemorrhagic stroke;Uncontrolled endocrine disease known to influence serum lipids;Any clinically significant abnormality that in the judgment of the investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases,patients with short life expectancy,patients who cannot tolerate subcutaneous injections;Use of ezetimibe or red yeast rice products within 4 weeks of screening;Use of systemic corticosteroids or use of fibrates,other than fenofibrate within 6 weeks of the screening;eGFR <30mL/min/1.73m2;ALT or AST aminotransferase >3 x upper linit of normal (ULN);CPK >3 x ULN;TSH < lower limit of normal (LLN);Hypersensitivity to monoclonal antibody therapeutics;Pregnant or breast-feeding women;Women of chilbearing potential with no effective contraceptive method of birth control.
    LDL-C &lt;70mg/dL (&lt;1.81mmol / l) in pazienti con CVD;LDL-C &lt;100mg/dL (&lt;2.59mmol / l) in pazienti senza CVD, ma con altri fattori di rischio;LDL-C&gt; 250 mg / dL o TG&gt; 400mg/dL;FH omozigote o pazienti trattati con plasmaferesi per eventi CV nei 3 mesi precedenti allo screening;NYHA classe III o IV insufficienza cardiaca; storia di ictus emorragico;malattia endocrina non controllata nota influenzare lipidi sierici;Qualsiasi clinicamente significativa anomalia che a giudizio dello sperimentatore precluderebbe il completamento sicuro dello studio o possa limitare la valutazione di endpoints come le principali malattie sistemiche,i pazienti con breve aspettativa di vita,i pazienti che non tollerano iniezioni sottocutanee;l'uso di ezetimibe prodotti contenenti lievito di riso rosso entro le 4 settimane di screening;l'uso di corticosteroidi sistemici o l'uso di fibrati, oltre fenofibrato entro 6 settimane dallo screening; eGFR &lt;30mL/min/1.73m2; ALT o AST aminotransferasi&gt; 3 volte superiore la norma (ULN); CPK&gt; 3 x ULN; TSH &lt;limite inferiore di normalità (LLN), Ipersensibilità alle terapie con anticorpi monoclonali, le donne in gravidanza o in allattamento, donne fertili che non utilizzano nessun metodo contraccettivo efficace di controllo delle nascite.
    E.5 End points
    E.5.1Primary end point(s)
    The percent change in calculated LDL-C from baseline to week 24.
    La variazione percentuale del C-LDL calcolata dal basale alla settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 24.
    Dal baseline alla settimana 24.
    E.5.2Secondary end point(s)
    -The percent change in calculated LDL-C from baseline to week 12. -The percent change in ApoB from baseline to week 24. -The percent change in non-HDL-C from baseline to week 24. -The percent change in total-C from baseline to week 24. -The percent change in ApoB from baseline to week 12. -The percent change in non-HDL-C from baseline to week 12. -The percent change in total-C from baseline to week 12. -The proportion of patients reaching LDL-C goal at week 24. -The percent change in Lp(a) from baseline to week 24. -The percent change in HDL-C from baseline to week 24. -The percent change in HDL-C from baseline to week 12. -The percent change in Lp(a) from baseline to week 12. -The percent change in fasting TG from baseline to week 24. -The percent change in fasting TG from baseline to week 12. -The percent change in ApoA-1 from baseline to week 24. -The percent change in ApoA-1 from baseline to week 12.
    -la variazione percentuale del C-LDL calcolata dal basale alla settimana 12 -la variazione percentuale dei valori di ApoB dal basale alla settimana 24 -la variazione percentuale dei valori del colesterolo non-HDL dal basale alla settimana 24 -la variazione percentuale dei valori del colesterolo totale dal basale alla settimana 24. -la variazione percentuale dei valori di ApoB dal basale alla settimana 12 -la variazione percentuale dei valori del colesterolo non-HDL dal basale alla settimana 12 -la variazione percentuale dei valori del colesterolo totale dal basale alla settimana 12. -la proporzione di pazienti che raggiunge valori di C-LDL previsti alla settimana 24 -la variazione percentuale dei valori di Lp(a) dal basale alla settimana 24 -la variazione percentuale dei valori del C-HDL dal basale alla settimana 24 -la variazione percentuale dei valori del C-HDL dal basale alla settimana 12 -la variazione percentuale dei valori di Lp(a) dal basale alla settimana 12 -la variazione percentuale dei valori di TG a digiuno dal basale alla settimana 24 -la variazione percentuale dei valori di TG a digiuno dal basale alla settimana 12 -la variazione percentuale dei valori di ApoA-1 dal basale alla settimana 24. -la variazione percentuale dei valori di ApoA-1 dal basale alla settimana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to week 12 or week 24.
    Dal baseline alla settimana 12 o 24.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Comparatore attivo
    Active-comparator
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Canada
    Mexico
    New Zealand
    United States
    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 years0
    E.8.9.1In the Member State concerned months16
    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 months16
    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.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 361
    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)
    None
    Nessuno
    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 Decision2013-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-06
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