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    Summary
    EudraCT Number:2012-001221-27
    Sponsor's Protocol Code Number:R727-CL-1119
    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 number2012-001221-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins
    Studio randomizzato in doppio cieco e a doppia simulazione con farmaco di controllo per la valutazione della sicurezza e dell'efficacia di REGN727/SAR236553 in pazienti affetti da ipercolesterolemia primaria intolleranti alle statine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of REGN727/SAR236553 in patients with primary hypercholesterolemia who are intolerant to statins
    Efficacia e sicurezza di REGN727/SAR236553 in pazienti affetti da ipercolesterolemia primaria intolleranti alle statine
    A.3.2Name or abbreviated title of the trial where available
    Odyssey - Alternative
    Odyssey - Alternative
    A.4.1Sponsor's protocol code numberR727-CL-1119
    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 pointDan Gipe, MD
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 914 298 5496
    B.5.5Fax number001 914 298 5496
    B.5.6E-maildan.gipe@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 INNREGN727
    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 typeup to
    D.3.10.3Concentration number150
    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 Zetia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    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 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.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 Atorvastatin Calcium
    D.2.1.1.2Name of the Marketing Authorisation holderRanbaxy
    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 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 INNATORVASTATIN CALCIUM
    D.3.9.1CAS number 134523-03-8
    D.3.9.4EV Substance CodePRD100305
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 3
    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
    Patients with primary hypercholesterolemia and moderate, high or very high cardiovascular (CV) risk who are intolerant to statins
    Pazienti affetti da ipercolesterolemia primaria e rischio cardiovascolare (CV) moderato, elevato o molto elevato che sono intolleranti alle statine.
    E.1.1.1Medical condition in easily understood language
    High blood cholesterol level
    Livello di colesterolo alto 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 SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    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
    The primary objective of the study is to demonstrate the reduction of low-density lipoprotein (LDL) cholesterol (LDL-C) by REGN727 in comparison with ezetimibe (EZE) 10 mg PO QD after 24 weeks in patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [heFH] and non-familial hypercholesterolemia [FH]) who are intolerant to statins.
    L'obiettivo primario dello studio è dimostrare la capacità di REGN727 di ridurre il colesterolo delle lipoproteine a bassa densità (C-LDL) in confronto alla somministrazione orale quotidiana di ezetimibe (EZE) 10 mg dopo 24 settimane in pazienti affetti da ipercolesterolemia primaria [ipercolesterolemia familiare eterozigote (heFH) e ipercolesterolemia non familiare (FH)] intolleranti alle statine.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of REGN727 75 mg in comparison with EZE on LDL-C after 12 weeks of treatment - To evaluate the effect of REGN727 on other lipid parameters (ie, ApoB, non-HDL-C, total-C, Lp(a), HDL-C, TG levels, and ApoA-1 levels) - To evaluate the safety and tolerability of REGN727, including the characterization of the incidence rate and treatment withdrawal rate of skeletal muscle-related adverse events (AEs) - To evaluate the development of anti-REGN727 antibodies
    Gli obiettivi secondari dello studio comprendono: - la valutazione dell'effetto di REGN727 75 mg in confronto a EZE sul C-LDL dopo 12 settimane di trattamento - la valutazione dell'effetto di REGN727 su altri parametri dei lipidi (ovvero, ApoB, colesterolo non-HDL, colesterolo totale, Lp(a), C-HDL, livelli di TG e di ApoA-1) - la valutazione della sicurezza e della tollerabilità di REGN727, compresa la caratterizzazione dei tassi di incidenza e di sospensione del trattamento per eventi avversi (EA) muscolo-scheletrici - la valutazione dello 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:2012/06/25
    Title:A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins
    Objectives:to identify genetic associations with clinical or biomarker response to PCSK9 inhibition, hyperlipidemia, or CVD.

    FARMACOGENOMICA:
    Vers:1
    Data:2012/06/25
    Titolo:Studio randomizzato in doppio cieco e a doppia simulazione con farmaco di controllo per la valutazione della sicurezza e dell'efficacia di REGN727/SAR236553 in pazienti affetti da ipercolesterolemia primaria intolleranti alle statine
    Obiettivi:Identificare associazioni genetiche con la risposta clinica o del biomarker all'inibizione di PCSK9, iperlipidemia o CVD.

    E.3Principal inclusion criteria
    1. Patients with primary hypercholesterolemia (heFH* or non-FH) with moderate, high or very high CV risk** and a history of statin intolerance*** * Diagnosis of heFH must be made either by genotyping or by clinical criteria. For patients who are not genotyped, the clinical diagnosis must be a certain/definite diagnosis and may be based on either the Simon Broome criteria or the WHO/Dutch Lipid Network criteria. ** Moderate, high, and very high CV risk as defined in section 4.2. *** Definition of statin intolerance: Inability to tolerate at least 2 previous statins at the lowest approved daily dose due to skeletal muscle-related symptoms, other than those due to strain or trauma, such as pain, aches, weakness, or cramping, that began or increased during statin therapy and stopped when statin therapy was discontinued. 2. Provide signed informed consent
    1. Pazienti con ipercolesterolemia primaria (heFH* o non-FH) con rischio CV moderato, alto o molto alto** e una storia di intolleranza alle statine***
    * La diagnosi di heFH deve essere effettuata tramite genotipizzazione o criteri clinici. Per i pazienti che non sono stati genotipizzati, la diagnosi clinica deve essere una diagnosi certa/definita e può essere basata sui criteri di Simon Broome o sui criteri di OMS/Dutch Lipid Network.
    ** Rischio CV moderato, alto e molto alto come definito nella sezione 4.2.
    *** Definizione di intolleranza alle statine: incapacità di tollerare almeno 2 statine precedentemente assunte al dosaggio quotidiano minimo approvato a causa di sintomi muscolo-scheletrici diversi da quelli imputabili a sforzo o trauma, quali dolore, debolezza o crampi, cominciati o aggravatisi nel corso della terapia statinica e cessati alla sua sospensione.
    2. Fornire consenso informato scritto
    E.4Principal exclusion criteria
    1. Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit 2. Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit 3. A 10-year fatal CVD risk SCORE < 1% at the screening visit 4. Use of a statin that is at or above the lowest approved daily dose within 4 weeks prior to the screening visit 5. Experienced skeletal muscle-related adverse event(s), other than those due to strain or trauma during the 4-week single-blind placebo run-in 6. Experiencing a skeletal muscle-related adverse event(s), other than those due to strain or trauma at the time of screening, start of singleblind placebo run-in period, or day 1/week 0 7. Not on a stable dose of LMT for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit or from screening to randomization, as applicable 8. Use of fibrates, other than fenofibrate, within 6 weeks of the screening visit 9. Use of nutraceuticals or over-the-counter (OTC) therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit or between the screening and randomization visits 10. Use of red yeast rice from the screening visit to the end-of-study visit 11. Use of analgesics for which the dose is not planned to be stable from the screening visit to the end-of-study visit 12. Diagnosis of fibromyalgia 13. History of severe neuropathic pain 14. History of rheumatological disease associated with symptoms that may be confounded with symptoms of statin intolerance, e.g., rheumatoid arthritis 15. History of myalgia or myopathy that began or increased during treatment with lipid modifying therapy (LMT), other than statin therapy, and stopped when the LMT was discontinued 16. Known history of seizure disorder 17. History of previous transplant surgery 18. Use of medications that require intramuscular administration, or planned intramuscular injections during the study 19. Known history of myopathy, other than statin-associated myopathy 20. History of rhabdomyolysis (defined as evidence of organ damage with creatine kinase (CK) > 10,000 IU/L)
    1. Livelli di C-LDL sierico &lt;70 mg/dL (1,81 mmol/L) e rischio CV molto alto alla visita di screening
    2. Livelli di C-LDL sierico &lt;100 mg/dL (2,59 mmol/L) e rischio CV alto o moderato alla visita di screening
    3. Uno SCORE del rischio di malattia cardiovascolare (CVD) fatale in un arco temporale a 10 anni &lt; 1% alla visita di screening
    4. Uso di una statina che sia del dosaggio quotidiano minimo o superiore entro 4 settimane prima della visita di screening
    5. Evento/i avverso/i muscolo-scheletrico/i manifestato/i, diverso/i da quelli imputabili a sforzo o trauma durante il periodo di run-in del placebo di 4 settimane in singolo cieco
    6. Evento/i avverso/i muscolo-scheletrico/i manifestato/i, diverso/i da quelli imputabili a sforzo o trauma all’atto dello screening, inizio del periodo di run-in del placebo in singolo cieco, o giorno 1/settimana 0
    7. Non su una dose stabile di LMT per almeno 4 settimane e/o fenofibrato per almeno 6 settimane, a seconda dei casi, prima della visita di screening o dallo screening alla randomizzazione, a seconda dei casi
    8. Uso di fibrati, diversi dal fenofibrato, entro 6 settimane dalla visita di screening
    9. Uso di nutraceutici o farmaci da banco (OTC) noti per influire sui lipidi, ad una dose/quantità che non è stata stabile per almeno 4 settimane prima della visita di screening o tra le visite di screening e la randomizzazione
    10. Uso di lievito di riso rosso dalla visita di screening alla visita di fine studio
    11. Uso di analgesici la cui dose non viene pianificata come stabile dalla visita di screening alla visita di fine studio
    12. Diagnosi di fibromialgia
    13. Storia di grave dolore neuropatico
    14. Storia di malattia reumatologica associata ai sintomi che possono essere confusi con i sintomi dell’intolleranza alle statine, ad es. l’artrite reumatoide
    15. Storia di mialgia o miopatia iniziata o aumentata durante il trattamento con la terapia modificante dei lipidi (LMT), diversa dalla terapia statinica e interrotta quando la LMT è stata sospesa
    16. Storia nota di crisi convulsive
    17. Pregresso trapianto chirurgico
    18. Uso di farmaci che necessitano di somministrazione intramuscolare o iniezioni intramuscolari pianificate durante lo studio
    19. Storia nota di miopatia, diversa dalla miopatia associata alle statine
    20. Storia di rabdomiolisi (definita come evidenza di danno agli organi con creatinchinasi (CK) &gt; 10.000 IU/L)
    E.5 End points
    E.5.1Primary end point(s)
    The percent change in calculated LDL-C.
    L'endpoint primario di efficacia è la variazione percentuale del C-LDL calcolato 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, ie, LDL-C <70 mg/dL (1.81 mmol/L) in case of very high CV risk or LDL-C <100 mg/dL (2.59 mmol/L) for patients with moderate or high CV risk. - The proportion of patients reaching LDL-C <70 mg/dL (1.81 mmol/L) 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 calcolato 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 percentuale di pazienti che raggiunge l'obiettivo del C-LDL alla settimana 24, ovvero C-LDL <70 mg/dL (1,81 mmol/L) in caso di rischio CV molto elevato oppure C-LDL <100 mg/dL (2,59 mmol/L) per i pazienti con rischio CV moderato o elevato - la percentuale di pazienti che raggiunge valori di C-LDL <70 mg/dL (1,81 mmol/L) 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 weeks 12 and 24.
    Dal baseline alla settimana 12 e 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
    a doppia simulazione con farmaco di controllo
    Double-Dummy, Active-Controlled
    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 trial3
    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 EEA18
    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
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 250
    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 Decision2013-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
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