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    Summary
    EudraCT Number:2016-002176-27
    Sponsor's Protocol Code Number:HC-G-H-1505
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2017-04-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002176-27
    A.3Full title of the trial
    Pragmatic, prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of a 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in trauma patients
    Estudio prospectivo, aleatorizado, doble-ciego, internacional y multicéntrico sobre la seguridad y la eficacia de la solución 6% Hydroxy-ethyl starch (HES) comparada con una solución electrolítica en pacientes traumatizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pragmatic, controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl-starch (HES) solution versus an electrolyte solution in trauma patients
    Estudio para investigar la seguridad y eficacia de un sustituto de volumen plasmático que contiene hydroxyethyl-starch (HES) en pacientes con sangrado súbito tras un traumatismo
    A.3.2Name or abbreviated title of the trial where available
    TETHYS
    A.4.1Sponsor's protocol code numberHC-G-H-1505
    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 SponsorB. Braun Melsungen AG
    B.1.3.4CountryGermany
    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 supportB. Braun Melsungen AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationB. Braun Medical SA
    B.5.2Functional name of contact pointRicard Rosique
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Terrassa, 121
    B.5.3.2Town/ cityRubi
    B.5.3.3Post code08191
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935902283
    B.5.5Fax number0034935902257
    B.5.6E-mailricard.rosique@bbraun.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 Yes
    D.2.1.1.1Trade name Volulyte 6% solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoly(O-2-hydroxyethyl)starch
    D.3.9.1CAS number 9005-27-0
    D.3.9.3Other descriptive nameHYDROXYETHYL STARCH 130/0.4
    D.3.9.4EV Substance CodeSUB90155
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 61341-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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: 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 IONOLYTE solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi España S.A.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 61341-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypovolaemia due to acute blood loss in trauma surgery
    Tratamiento de hipovolemia debido a la pérdida de sangre aguda en pacientes traumatizados
    E.1.1.1Medical condition in easily understood language
    Decreased blood volume due to acute blood loss in trauma patients
    Disminución del volumen sanguíneo (hipovolemia) debida a hemorragia aguda en pacientes con traumatismo.
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10021137
    E.1.2Term Hypovolaemia
    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
    Investigate the safety of a 6% HES solution versus an electrolyte solution in trauma patients
    Investigar la seguridad de una solución 6% HES frente a una solución electrolítica en pacientes traumatizados
    E.2.2Secondary objectives of the trial
    Further investigation of safety and efficacy of the applied products
    Investigación adicional sobre la seguridad y la eficacia de los productos de investigación empleados
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female adult patients ≥ 18 and ≤ 80 years of age
    Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
    Patients with blunt or penetrating trauma suffering from an estimated blood loss of ≥ 500 ml
    Initial surgery deemed necessary within 24 hours after trauma
    Deferred signed written informed consent form or as locally required
    No signs of intracranial or cerebral haemorrhage
    Base excess < - 4 mEq/l
    Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission
    Pacientes adultos de ambos géneros de entre ˃ 18 a ≤ 80 años de edad. Las mujeres en edad fértil deben dar resultado negativo en un test de embarazo (plasma u orina) (si es posible)
    Pacientes con traumatismo penetrante o contundente que sufren una pérdida de sangre estimada ≥ 500 ml
    Cirugía inicial prevista en las primeras 24 horas tras el traumatismo
    Consentimiento informado diferido firmado como lo requieran las autoridades locales
    No signos de hemorragia intracraneal o cerebral
    Exceso de base ˂ -4 mEq/l
    Administración de menos de 15 ml/kg de coloides entre el traumatismo y la hospitalización
    E.4Principal exclusion criteria
    Hypersensitivity to the active substances or to any of the other excipients of the investigational products
    Body weight ≥ 140 kg
    Patients expected to die within 24 hours after traumatic injury
    Sepsis
    Burns
    Renal impairment (AKIN stage ≥ 1) or acute and/or chronic renal replacement therapy
    Critically ill patients (typically admitted to the intensive care unit)
    Dehydration
    Hyperhydration
    Pulmonary oedema
    Congestive heart failure
    Hyperkalaemia
    Severe hypernatraemia
    Severe hyperchloraemia
    Metabolic alkalosis
    Severely impaired hepatic function
    Severe coagulopathy
    Organ transplant patients
    Simultaneous participation in another clinical interventional trial (drugs or medical devices)
    Hipersensibilidad a la sustancias activas o a cualquier excipiente de los productos médicos en investigación
    Peso corporal ≥ 140 kg
    Pacientes que se espera que mueran en las siguientes 24 horas al traumatismo
    Sepsis
    Quemaduras
    Trastorno renal (estado AKIN ≥ 1) o terapia de reemplazo renal aguda o crónica
    Pacientes críticos (típicamente admitidos en la unidad de cuidados intensivos)
    Deshidratación
    Hiperhidratación
    Edema pulmonar
    Insuficiencia cardiaca congestiva
    Hiperpotasemia
    Hipernatremia severa
    Hipercloremia severa
    Alcalosis metabólica
    Función hepática gravemente deteriorada
    Coagulopatía severa
    Pacientes con trasplante de órganos
    Participación simultánea en otros ensayos clínicos de intervención (estudios con medicamentos o dispositivos médicos)
    E.5 End points
    E.5.1Primary end point(s)
    Composite primary endpoint: 90 day mortality and 90 day renal failure

    Mortality: differentiation between in-hospital and out of hospital will be made
    Renal failure is defined as biomarker increase as defined by AKIN stage 2 or RIFLE category injury or need for renal replacement therapy (RRT), including haemodialysis, peritoneal dialysis, haemofiltration, and renal transplantation at any time during the first 3 months.
    Criterio de valoración de mortalidad y fallo renal (definido como aumento de biomarcador como se define en las escalas AKIN II, o RIFLE, o tratamiento de reemplazo renal (RRT) durante cualquier momento en los primeros tres meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    At hospital admission and discharge
    At ICU admission and discharge
    90 day mortality and renal failure evaluation at day 90 ± 14 days (Timepoint 4 (T4) = 90 days after randomization)
    Al ingreso y al alta hospitalarias
    Al ingreso y al alta en UCI
    Mortalidad a 90 días y evaluación de fallo renal al día 90 ± 14 (Tiempo 4 (T4) = 90 días después de la aleatorización)
    E.5.2Secondary end point(s)
    Safety
    - Renal function: Serum creatinine (SCr), Cystatin-C, SCr based eGFR, Cystatin-C based estimated glomerular filtration rate (eGFR), Cystatin-C based mean eGFR, AKIN stage, highest AKIN on each day (during the first week), RIFLE category, urine output (if available)
    - Coagulation: Platelet count, International norm ratio (INR), activated partial thromboplastin time (aPTT)
    - Inflammation: C-reactive protein (C-RP)
    - Adverse events: (serious) adverse events ((S)AEs / reactions ((S)ARs)
    - Outcome: Length of stay (LOS) in the hospital (LOS-H), LOS in the intensive care unit (LOS-ICU); fit for discharge from ICU / hospital, need for mechanical ventilation / duration of mechanical ventilation (MV), Mortality (in-hospital / out of hospital) and its cause, need for renal replacement therapy (RRT) / duration of RRT

    Efficacy
    - Fluid administration: administration of IP volume
    - Fluid balance: fluid input and output
    - Haemodynamics / vital signs: Temperature (T), heart rate (HR), mean arterial pressure (MAP, calculated), systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), central venous pressure (CVP, if available)
    - and at least one of the following parameters to evaluate responsiveness and guide administration (vol guide): stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), pulse pressure variation (PPV), mean arterial pressure (measured)
    Arterial Blood Gas Analysis (ABGA): partial pressure of carbondioxide (pCO2), partial pressure of oxygen (pO2), hydrogen carbonate (HCO3-), arterial oxygen saturation (SaO2), haemoglobin (Hb), haematocrit (Hct), pH, base excess (BE), lactate
    centralvenous oxygen saturation (ScvO2)
    Serum electrolytes (S elyte): Sodium, potassium, calcium, chloride

    Definition of time-points
    Screening at hospital admission
    T0 (Baseline, emergency room)
    T1 (first 24 hours after randomization)
    T2 (post-traumatic day 1-3)
    T3 (post-traumatic day 4-7)
    T4 (day 90 after randomization)
    Seguridad
    -Función renal: Cistatina-C, Creatinina sérica (Crs), Tasa de filtración glomerular estimada (TFGe) basada en cistatina-C, Media de TFG estimada basada en cistatina-C, Crs basado en TFGe, Insuficiencia Renal Aguda (IRA) -estadio AKIN- el estadio más alto cada día (durante la primera semana), Escalas AKIN y RIFLE, Producción de orina
    -Coagulación: Recuento plaquetario, Relación normalizada internacional (INR), Tiempo activación parcial de la tromboplastina (PTTa)
    - Inflamación: Proteína C-reactiva
    - Eventos adversos: Eventos o reacciones adversos (serios) ((S)EAS/(S)RAS)
    Resultados: Duración de la estancia hospitalaria (LOS), Duración de la estancia hospitalaria en la unidad de cuidados intensivos (UCI) (si aplica), Razón del alta UCI/hospital, Horas de ventilación mecánica, Mortalidad dentro o fuera del hospital (incluida causa), Terapia de reemplazo renal (TRR)

    Eficacia
    -Administración de fluidos
    - Administración de volumen de producto en investigación
    - Balance de fluidos: Entrada y salida de fluidos
    - Signos vitales/hemodinámicos: Ritmo cardiaco (FC), Temperatura (T),
    - Presión arterial media (PAM), Presión arterial sistólica (PAS), Presión arterial diastólica (PAD), Presión venosa central (PVC) (si está disponible)
    - Al menos uno de los siguiente parámetros para evaluar la respuesta a volumen y orientar la administración del producto en investigación dentro del algoritmo de volume: Volumen sistólico (VS), Variación del volumen sistólico (VVS), Índice de volumen sistólico (IVS), Variación en la presión de pulso (VPP), Presión arterial media (PAM)

    -Análisis de gases arteriales (GAB): Presión parcial de dióxido de carbono (pCO2), Presión parcial de oxígeno (pO2), Bicarbonato (HCO3-), Saturación arterial de oxígeno (SaO2), Hemoglobina (Hb), Hematocrito
    (Hct), pH, Exceso de bases, Lactato
    -Saturación venosa central de oxígeno (si está disponible)
    -Electrolitos en suero: Sodio (Na+), Potasio (K+), Calcio (Ca2+), Cloro (Cl-)

    Selección en la admisión hospitalaria
    T0 Base de referencia (sala de emergencias)
    T1 (Primeras 24 horas tras la aleatorización)
    T2 (Mañana días 1-3 postraumatismo)
    T3 (Mañana días 4-7 postraumatismo)
    T4 (día 90 después de la aleatorización ± 14 días)
    E.5.2.1Timepoint(s) of evaluation of this end point
    SCr & SCr-based eGFR: T0, T1 (every 6 hours), T2, T3
    Cystatin-C: T0, T1 (every 6 hours), T2
    Cystatin-C-based eGFR: T0
    Cystatin-C-based mean eGFR: T1, T2
    AKIN stage: T0, T1 (every 6 hours), T2, T3
    highest AKIN stage: T1, T2, T3
    RIFLE category: T0, T1 (every 6 hours), T2, T3
    Urin output: T0, T1 (every 6 hours), T2, T3
    Coagulation: T0, T1 (every 6 hours), T2, T3
    C-RP: T0, T1 (every 6 hours), T2, T3
    (S)AEs/(S)ARs: T0-T3
    LOS-H, LOS-ICU, Fit for discharge - H & ICU: daily
    MV: screening - T3
    Mortality: T1-T4
    RRT : T1-T4
    IP intake, fluid in-/output, fluid bal: T0-T3
    T: T0-T3
    HR, MAP, SAP, DAP, CVP: T0, T1 (every 6 hours), T2, T3
    vol guide: during IP admin
    ABGA: T0, T1 (every 6 hours), T2, T3
    ScvO2: T0, T1 (every 6 hours), T2, T3
    S Elyte: T0, T1 (every 6 hours), T2, T3
    Cistatina-C: T0, T1 (todos 6 h), T2
    Crs & Crs basado en TFGe: T0, T1 (todos 6 h), T2, T3
    TFGe basada en cistatina-C: T0
    Media de TFG estimada basada en cistatina-C: T1, T2
    IRA -estadio AKIN- el estadio más alto cada día:T1, T2, T3
    Escalas AKIN y RIFLE: T0, T1 (todos 6 h), T2, T3
    Producción de orina: T0, T1 (todos 6 h), T2, T3
    Coagulación: T0, T1 (todos 6 h), T2, T3
    C-RP: T0, T1 (todos 6 h), T2, T3
    (S)EAs/(S)RAs: T0-T3
    LOS-H, LOS-UCI, Razón del alta UCI/hospital:diario
    VM: Selección-T3
    Mortalidad: T1-T4
    TRR: T1-T4
    Balance de fluidos: T0-T3
    T: T0-T3
    FC, PAM, PAS, PAD, PVC: T0, T1 (todos 6 h), T2, T3
    Administración de volumen de producto en investigación: T0-T1
    GAB: T0, T1 (todos 6 h), T2, T3
    ScvO2: T0, T1 (todos 6 h), T2, T3
    Electrolitos: T0, T1 (todos 6 h), T2, T3
    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 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) No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Serbia
    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
    Day 7 after randomization of the last patient at the last site
    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.1.1.1In 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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-04-21. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Trauma patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 350
    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)
    Not different from the expected normal treatment of the condition.
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-30
    P. End of Trial
    P.End of Trial StatusRestarted
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