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    Summary
    EudraCT Number:2012-002219-25
    Sponsor's Protocol Code Number:ITCA650-CLP-107
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-002219-25
    A.3Full title of the trial
    A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes
    Estudio aleatorizado y multicéntrico para evaluar el efecto de ITCA 650 sobre los parámetros cardiovasculares en pacientes que reciben terapia estándar para la diabetes tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes
    Estudio para Evaluar el Efecto de ITCA 650 sobre los Parámetroa Cardiovasculares en Pacientes que Reciben Terapia Estándar para la Diabetes tipo 2
    A.4.1Sponsor's protocol code numberITCA650-CLP-107
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01455896
    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 SponsorIntarcia Therapeutics, 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 supportIntarcia Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntarcia Therapeutics, Inc
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address24650 Industrial Blvd
    B.5.3.2Town/ cityHayward CA
    B.5.3.3Post code94545
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1510782 7800
    B.5.5Fax number+1510782 7801
    B.5.6E-mailclinicaltrials@intarcia.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 nameITCA 650 20 mcg/day
    D.3.2Product code ITCA 650 20 mcg/day
    D.3.4Pharmaceutical form Implant
    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 INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.9.4EV Substance CodeSUB21818
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 Yes
    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 typesynthetic peptide
    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 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 nameITCA 650 60 mcg/day
    D.3.2Product code ITCA 650 60 mcg/day
    D.3.4Pharmaceutical form Implant
    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 INNEXENATIDE
    D.3.9.1CAS number 141758-74-9
    D.3.9.4EV Substance CodeSUB21818
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    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 typesynthetic peptide
    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 placeboImplant
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    Diabetes Tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabetes Tipo 2
    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 10067585
    E.1.2Term Type 2 diabetes mellitus
    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 Study 107 is to obtain CV event data that will be pooled with CV event data from other pivotal Phase 3 studies in a meta-analysis to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) in adult patients on Standard of Care for T2D receiving either ITCA 650 or control, based on the time to first occurrence of any event in the MACE1 CV composite endpoint (CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), does not exceed 1.8.
    El objetivo principal del estudio 107 es recabar datos de acontecimientos CV que se agruparán con los datos de los acontecimientos CV de otros estudios fundamentales de fase 3 en un metaanálisis con el fin de demostrar que el límite superior del intervalo de confianza al 95 % del cociente de riesgos instantáneos de acontecimientos cardíacos adversos importantes (ACAI) en pacientes adultos a los que se administra tratamiento según las normas de asistencia médica para la DT2 y que reciben ITCA 650 o control en función del tiempo hasta la aparición por primera vez de cualquier acontecimiento del criterio de valoración CV compuesto de ACAI-1 (muerte por causas CV, IM no mortal, accidente cerebrovascular no mortal u hospitalización por angina inestable) no excede de 1,8.
    E.2.2Secondary objectives of the trial
    The secondary objective of Study 107 is to use CV event data obtained from Study 107 alone to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of MACE in adult patients on Standard of Care for T2D receiving either ITCA 650 or control, based on the time to first occurrence of any event in the MACE2 CV composite endpoint that excludes hospitalization for unstable angina (CV death, non-fatal MI, or non-fatal stroke), does not exceed 1.3.
    El objetivo secundario del estudio 107 es utilizar los datos de los acontecimientos CV obtenidos sólo del estudio 107 para demostrar que el límite superior del intervalo de confianza al 95 % del cociente de riesgos instantáneos de ACAI en pacientes adultos a los que se administra tratamiento según las normas de asistencia médica para la DT2 y que reciben ITCA 650 o control, en función del tiempo hasta la aparición por primera vez de cualquier acontecimiento del criterio de valoración CV compuesto de ACAI-2, que excluye la hospitalización por angina inestable (muerte por causas CV, IM no mortal o accidente cerebrovascular no mortal), no excede de 1,3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with a diagnosis of T2D
    2. Patients with HbA1c ?6.5% at Screening.
    3. High-risk group defined as males and females ?40 years old with at least one documented occurrence of: CAD, cerebrovascular disease, or symptomatic peripheral arterial disease whose disease, in the Investigator's opinion, is stable, and not in the acute recovery stage of a CV event (i.e., event listed below to have occurred at LEAST 1 month prior to Screening, unless otherwise specified)
    4. Low-risk group defined as males and females ?60 years old with at least one other risk factor in addition to T2D
    5. Patients with understanding of the study procedures and agreement to participate in the study by giving written informed consent in accordance with local regulations and the Institutional Review Board (IRB)/Ethics Committee (EC) governing the study site at or prior to Screening;
    6. Current treatment with an intermediate-acting and / or long-acting insulin or intermediate and / or long-acting insulin analogue is allowed; if the screening HbA1c value is ?8.0%, then the total daily dose of intermediate-acting and/or long-acting insulin or intermediate and/or long-acting insulin analogue will be reduced by 20% at randomization
    7. Patients who are on a stable treatment regimen of diet and exercise alone or who are being treated with oral monotherapy or oral combination antidiabetic therapy with the exception of a dipeptidylpeptidase-4 (DPP-4) inhibitor or a glucagonlike peptide (GLP)-1 agonist
    8. Calcitonin <50 pg/mL (ng/L) at Screening;
    9. Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and for one additional menstrual cycle following the End-of-Treatment (ET) Visit.
    1. Pacientes con diagnóstico de DT2
    2. Paciente con un nivel de HbA1c ? 6,5 % en la selección.
    3. Grupo de riesgo alto, definido como varones y mujeres ? 40 años con al menos un acontecimiento confirmado de arteriopatía coronaria (APC), enfermedad cerebrovascular, o arteriopatía periférica sintomática, que, en opinión del investigador, presenten enfermedad estable, y no se encuentren en la fase aguda de recuperación de un acontecimiento CV (es decir, acontecimiento incluido en la lista que se proporciona a continuación que se haya producido AL MENOS 1 mes antes de la selección, salvo que se indique lo contrario);
    4. Grupo de riesgo bajo, definido como varones y mujeres ? 60 años con al menos otro factor de riesgo además de DT2 ;
    5. Pacientes que comprendan los procedimientos del estudio y acepten participar en él otorgando su consentimiento informado por escrito, ya sea en el momento de la selección o antes, de conformidad con la normativa local y el Comité Ético de Investigación Clínica (CEIC) por el que se rija el centro del estudio;
    6. Pacientes que comprendan los procedimientos del estudio y acepten participar en él otorgando su consentimiento informado por escrito, ya sea en el momento de la selección o antes, de conformidad con la normativa local y el Comité Ético de Investigación Clínica (CEIC) por el que se rija el centro del estudio;
    7. Se permite insulina de acción intermedia y/o de acción prolongada o un análogo de la insulina de acción intermedia y/o prolongada; si el nivel de HbA1c es ? 8,0 % en la selección, entonces en la aleatorización la dosis diaria total de la insulina de acción intermedia y/o de acción prolongada o de un análogo de la insulina de acción intermedia y/o prolongada se reducirá en un 20 %.
    8. Pacientes en un régimen estable (? 3 meses antes de la selección) de tratamiento consistente en sólo dieta y ejercicio o en monoterapia antidiabética oral o tratamiento antidiabético combinado oral, con excepción de un inhibidor de la dipeptidil peptidasa-4 (DPP-4) o un agonista del GLP-1.
    9. Calcitonina < 50 pg/ml (ng/l) en la selección;
    10. Las mujeres con posibilidad de quedarse embarazadas deben dar negativo en la prueba de embarazo en la selección y deben comprometerse a utilizar un método anticonceptivo válido durante el estudio y durante un ciclo menstrual adicional tras la visita de fin de tratamiento (FdT).
    E.4Principal exclusion criteria
    1. Prior treatment with DPP-4 inhibitor or GLP-1 agonist within 3 months prior to Screening; 2. Current treatment with rapid-acting insulin or rapid-acting insulin analogues; 3. Requirement of treatment with immunosuppressants or medications that affect (GI) motility (see Appendix B); 4. Allergic reactions or intolerance to GLP-1 receptor agonists; 5. History of hypersensitivity to exenatide;6. Diagnosis of or history of: Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, Acute metabolic diabetic complications, major hypoglycemia; 7. History of acute or chronic pancreatitis; 8. Family or personal history of thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2); 9. Presence of a thyroid nodule detected on physical examination that has not been fully evaluated; 10. Thyroid-stimulating hormone (TSH) outside of normal limits at Screening. 11. Thyroid hormone therapy that has not been stable for ?6 weeks prior to Screening; 12. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary, or peripheral) procedures; 13. Current New York Heart Association (NYHA) Class III or IV heart failure; 14. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years; 15. Prior history of treatment with an investigational drug within 30 days prior to Screening Visit 1 (Days -28 to -2) or 5 half lives (whichever is longer); participation in a clinical study involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; 16. Laboratory abnormalities in FPG, ALT, AST, Bilirubin, Fasting triglycerides, GFR described in protocol. Patients taking metformin are excluded if serum creatinine levels are >1.5 mg/dL (132 µmol/L) for males, or >1.4 mg/dL (123 µmol/L) for females; 17. Uncontrolled hypertension at Screening defined as a systolic BP >180 mmHg and/or a diastolic BP >100 mmHg with or without antihypertensive medication (may be repeated after 15 minutes and exclusion based on last measurement); 18. History of positive serologic evidence of current infectious liver disease; 19. Presence of diabetic complications that, in the opinion of the Investigator, would complicate the patient?s participation in the study; 20.History of organ transplantation; 21. Known clinically significant gastric emptying abnormality (see Appendix B); 22. Donation of one unit (500 mL) or more of blood; significant blood loss equaling at least one unit of blood; or transfusion within 8 weeks prior to Screening;23. History or evidence of immunocompromised status; 24. History of active alcohol or substance abuse within 1 year prior to Screening; 25. Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to Screening; intra-nasal, intra-articular, intra-ocular, inhaled or topical steroids are permitted.
    1.Tratamiento previo con un inhibidor de la DPP-4 o un agonista del GLP-1 en los 3 meses anteriores a la selección; 2.Tratamiento actual con insulina de acción rápida o análogos de la insulina de acción rápida;3.Necesidad de tratamiento con inmunodepresores o medicamentos que afecten a la motilidad GI (véase Anexo B);4. Reacciones alérgicas o intolerancia a agonistas del receptor del GLP-1;5. Antecedentes de hipersensibilidad a la exenatida; 6.Diagnóstico o antecedentes de: Diabetes tipo 1, diabetes causada por lesión pancreática o formas secundarias de diabetes, Complicaciones diabéticas metabólicas agudas, Hipoglucemia grave; 7.Antecedentes de pancreatitis aguda o crónica; 8. Antecedentes familiares o personales de carcinoma tiroideo o neoplasia endocrina múltiple de tipo 2 (NEM2); 9. Presencia de nódulo tiroideo, detectado en un reconocimiento médico, que no se ha evaluado completamente;10.Hormona estimulante del tiroides (TSH) fuera de los límites de normalidad en la selección; se permite volver a analizarla una vez antes de la aleatorización;11. Tratamiento con hormona tiroidea que no haya permanecido estable en las ? 6 semanas previas a la selección;12. Cirugía cardíaca o procedimientos de revascularización arterial (carotídeos, coronarios o periféricos) programados; 13.Insuficiencia cardíaca de clase III o IV según la clasificación de la New York Heart Association (NYHA) 14.Neoplasia maligna diagnosticada y/o tratada (salvo carcinoma basocelular, carcinoma in situ de cuello de útero o cáncer de próstata in situ) en los últimos 5 años; podrán participar los pacientes que lleven > 5 años sin enfermedad;15. Tratamiento con un fármaco en fase de investigación en los 30 días previos a la visita 1 de selección (días ?28 a ?2) o en el periodo correspondiente a 5 semividas (lo que sea mayor) previo a dicha fecha; participación en un estudio clínico con un producto en fase de investigación o sobre un uso no autorizado de un fármaco o dispositivo; o participación simultánea en cualquier otro tipo de investigación médica que se considere que no es compatible científica o médicamente con este estudio;16.Anomalías analíticas en GPA, ALT, AST, Bilirrubina, Triglicéridos, FG descritas en el protocolo. Se excluirá a los pacientes que reciban tratamiento con metformina si presentan niveles de creatinina sérica > 1,5 mg/dl (132 ?mol/l) en el caso de los varones y > 1,4 mg/dl (123 ?mol/l) en el caso de las mujeres; 17.Hipertensión no controlada en la selección, definida como una PA sistólica en sedestación > 180 mm Hg y/o una PA diastólica en sedestación > 100 mm Hg (la medición puede repetirse después de 15 minutos y la exclusión se basará en la última medición); 18. Antecedentes o signos serológicos positivos de hepatopatía infecciosa en curso, incluida la hepatitis B o la hepatitis C. Podrá incluirse a pacientes de los que se hayan aislado anticuerpos contra el antígeno de superficie de la hepatitis B; 19.Presencia de complicaciones diabéticas que, en opinión del investigador, dificultarían la participación del paciente en el estudio; 20. Antecedentes de trasplante de órganos; 21. Anomalía conocida y clínicamente significativa en el vaciado gástrico (véase Anexo B); 22.Donación de una unidad (500 ml) o más de sangre; pérdida de sangre significativa equivalente a al menos una unidad de sangre; o transfusión en las 8 semanas previas a la selección;23.Antecedentes o signos de inmunodepresión, incluidos, entre otros, antecedentes de trasplante de órganos o infección documentada por el virus de la inmunodeficiencia humana;24.Antecedentes de alcoholismo o toxicomanías en el año previo a la selección;25.Tratamiento crónico (> 10 días consecutivos) con corticoides sistémicos en las 8 semanas previas a la selección; se permite no obstante el tratamiento con corticoides por vía intranasal, intraarticular, intraocular, inhalatoria y tópica.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of any event in the MACE composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina).
    Tiempo hasta la aparición por primera vez de cualquier acontecimiento del criterio de valoración compuesto de ACAI-1 (muerte por causas cardiovasculares, IM no mortal, accidente cerebrovascular no mortal u hospitalización por angina inestable).
    E.5.1.1Timepoint(s) of evaluation of this end point
    First occurrence of any event in the MACE composite endpoint
    La aparición por primera vez de cualquier acontecimiento incluido en el criterio de valoración compuesto ACAI
    E.5.2Secondary end point(s)
    Time to first occurrence of any event in the MACE2 composite endpoint (CV death, non-fatal MI, or non-fatal stroke)
    El tiempo hasta la aparición por primera vez de cualquier acontecimiento del criterio de valoración compuesto de ACAI-2 (muerte por causas cardiovasculares, IM no mortal o accidente cerebrovascular no mortal).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first occurrence of any event listed above
    La aparición por primera vez de cualquier acontecimiento listado anteriormente
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity: Anti-exenatide antibodies will be measured
    Inmunogenicidad: los anticuerpos contra exenatida serán medidos
    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) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Argentina
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Egypt
    Estonia
    Finland
    France
    Germany
    Hungary
    India
    Israel
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    Slovakia
    South Africa
    Spain
    Turkey
    Ukraine
    United Arab Emirates
    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
    Ultima Visita del Ultimo Paciente
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1500
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 991
    F.4.2.2In the whole clinical trial 3000
    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)
    Patients are to be informed that their study doctor (and/or regular physician) will work with them to determine the best course of therapy after the end of their treatment in the study. No additional treatment will be offered by the sponsor.
    Los pacientes son informados de que su médico del estudio (y / o médico de cabecera) trabajará con ellos para determinar el mejor tratamiento después de la finalización de su tratamiento en el ensayo. Ningún tratamiento adicional será ofrecido por el promotor
    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 Decision2013-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-11
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