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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42151   clinical trials with a EudraCT protocol, of which   6931   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005789-42
    Sponsor's Protocol Code Number:TDR14311
    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:2016-06-03
    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 number2015-005789-42
    A.3Full title of the trial
    Randomized, Double-blind, Placebo-controlled, Dose escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal Insulin
    Estudio aleatorizado, doble ciego controlado con placebo y de aumento escalonado de la dosis para evaluar la seguridad, farmacocinética y farmacodinámica de lixisenatida en pacientes pediátricos con diabetes mellitus tipo 2 no controlados adecuadamente con metformina y/o insulina basal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus (T2DM)
    Estudio de seguridad, farmacocinética y farmacodinámica de lixisenatida en pacientes pediátricos con diabetes mellitus tipo 2
    A.4.1Sponsor's protocol code numberTDR14311
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1176-6142
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 9400
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 Lyxumia
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS GROUPE
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 injection in pre-filled pen
    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 INNLixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lyxumia
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS GROUPE
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 injection in pre-filled pen
    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 INNLixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Lyxumia
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS GROUPE
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 injection in cartridge
    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 INNLixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 placeboSolution for injection in pre-filled pen
    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
    Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal Insulin
    Pacientes pediátricos con diabetes mellitus tipo 2 no controlados adecuadamente con metformina y/o insulina basal
    E.1.1.1Medical condition in easily understood language
    Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal Insulin
    Pacientes pediátricos con diabetes mellitus tipo 2 no controlados adecuadamente con metformina y/o insulina basal
    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 19.0
    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
    To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM.
    Demostrar la seguridad de dosis repetidas de lixisenatida de 5 μg, 10 μg y 20 µg durante 14 días en comparación con placebo en pacientes pediátricos con diabetes mellitus tipo 2
    E.2.2Secondary objectives of the trial
    -To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM.
    -To evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.
    -Evaluar las concentraciones plasmáticas de lixisenatida tras las dosis repetidas de 5 µg, 10 µg y 20 µg y los parámetros farmacocinéticos de las dosis repetidas de lixisenatida de 20 µg en pacientes pediátricos con DMT2
    - Evaluar el cambio respecto al nivel basal en las concentraciones de glucosa plasmática en ayunas y posprandial durante una prueba de ingesta de alimentos estandarizada tras dosis repetidas de lixisenatida de 5 μg, 10 μg y 20 µg en comparación con placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female patients aged ≥10 and <18 years old (at least 4 patients below 16 years old).
    -Body mass index (BMI) >85th percentile for age and gender; BMI ≤50 kg/m^2.
    -Male and female patients with documented T2DM insufficiently controlled with metformin ≥1000 mg/day (or maximum tolerated dose according to the Investigator’s judgment) at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (±20%) and regimen for 8 weeks prior to randomization.
    -Glycated hemoglobin (HbA1c) >6.5% and ≤11% at screening.
    -Pacientes de sexo masculino o femenino de edad ≥10 y <18 años (como mínimo 4 pacientes menores de
    16 años)
    -Índice de masa corporal (IMC) > percentil 85 por edad y sexo e IMC ≤50 kg/m2
    -Pacientes de sexo masculino y femenino con DMT2 documentada no controlados adecuadamente con metformina ≥1000 mg/día (o la dosis máxima tolerada según el criterio del investigador) a una dosis y pauta estables durante las 8 semanas anteriores a la aleatorización y/o con insulina basal a una dosis (±20 %) y pauta estables durante las 8 semanas anteriores a la aleatorización
    - HbA1c superior a 6,5 % y inferior o igual a 11 % en la selección
    E.4Principal exclusion criteria
    -If female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding.
    -Sexually active postmenarchal female patient who does not agree to use an adequate and highly
    effective method of contraception throughout the study duration and according to local regulation
    (ie, hormonal contraception, condom, etc.).
    -Diabetes other than T2DM.
    -Fasting plasma glucose >250 mg/dL (>13.9 mmol/L) at screening.
    -Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide [GLP-1] receptor agonist, dipeptidyl peptidase-IV [DPP-IV] inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit.
    -History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
    -Si sexo femenino, embarazo en curso (que se define como positivo de la prueba de embarazo en suero), en periodo de lactancia.
    - Paciente postmenárquicas, sexualmente activa que no esté de acuerdo en utilizar un método anticonceptivo adecuado y altamente
    eficaz durante toda la duración del estudio y de acuerdo con las regulaciones locales (Es decir, los anticonceptivos hormonales, preservativos, etc.).
    -Diabetes distinta de la DMT2.
    -Glucosa plasmática en ayunas superior a 250 mg / dl (> 13,9 mmol / L) en la selección
    -Uso de otros antidiabéticos orales o inyectables o agentes hipoglucemiantes distintos de metformina e insulina basal (por ejemplo, alfa inhibidor de la glucosidasa, péptido similar al glucagón [GLP-1] agonista de los receptores, inhibidores de la dipeptidil peptidasa-IV [DPP-IV] inhibidores, de acción corta insulina, etc.) dentro de 1 mes antes de la visita de selección.
    -Historia de pancreatitis inexplicable, pancreatitis crónica, pancreatectomía, cirugía de estómago / gástrico, enfermedad inflamatoria del intestino.
    E.5 End points
    E.5.1Primary end point(s)
    - Number of patients with adverse events (AEs)
    - Number of patients with treatment-emergent adverse events (TEAEs)
    - Number of patients with anti-lixisenatide antibodies
    - Número de pacientes con eventos adversos (AA)
    - Número de pacientes con eventos adversos emergentes del tratamiento (TEAEs)
    - Número de pacientes con anticuerpos anti-lixisenatide
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 10 weeks
    Hasta 10 semanas
    E.5.2Secondary end point(s)
    1 :
    - Assessment of PK parameters: lixisenatide plasma concentration
    - Assessment of pharmacodynamic parameters: plasma glucose AUC-0-4.5 hours, FPG, 1H-PPG excursion and 2H-PPG excursion

    2 :
    - Assessment of PK parameters: maximum concentration (Cmax)
    - Assessment of PK parameters: time to reach Cmax (Tmax)
    - Assessment of PK parameters: area under up to last concentration (AUClast)
    - Assessment of PK parameters: area under curve (AUC)
    1:
    - Evaluación de los parámetros farmacocinéticos: concentración plasmática lixisenatide
    - Evaluación de los parámetros farmacodinámicos: glucosa en plasma AUC-0-4,5 horas, FPG, 1H-PPG excursión y excursión 2H-PPG

    2:
    - Evaluación de los parámetros farmacocinéticos: concentración máxima (Cmax)
    - Evaluación de los parámetros farmacocinéticos: tiempo para alcanzar la Cmax (Tmax)
    - Evaluación de los parámetros farmacocinéticos: área bajo hasta última concentración (AUCfinal)
    - Evaluación de los parámetros farmacocinéticos: área bajo la curva (AUC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 : Day 14, Day 28 and Day 42
    2 : Day 42
    1: Día 14, Día 28 y el Día 42
    2: Día 42
    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 Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pediatric study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Ascending dose
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 28
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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
    Ninguno
    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 Decision2016-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-27
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