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    Summary
    EudraCT Number:2015-001832-39
    Sponsor's Protocol Code Number:LPS14060
    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:2015-09-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-001832-39
    A.3Full title of the trial
    A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six month extension.
    Ensayo mundo real pragmático, de 26 semanas con 6 meses de extensión, aleatorizado, abierto, de 2 brazos paralelos, para evaluar los resultados de los beneficios clínicos y de salud de la transición a Toujeo® en comparación a las insulinas de tratamiento estándar, en pacientes con Diabetes Mellitus Tipo 2 inadecuadamente controlada tratados con insulina basal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A ?Real World? Trial to determine efficacy and health outcomes of TOUJEO compared to ?standard of care? basal insulin in patients already using basal insulin.
    Ensayo "mundo real" para detarminar la eficacia y los resultados de salud de Toujeo® en comparación con las insulinas del tratamiento basal estándar en pacientes ya tratados con insulina basal
    A.3.2Name or abbreviated title of the trial where available
    REGAIN CONTROL
    REGAIN CONTROL
    A.4.1Sponsor's protocol code numberLPS14060
    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 Sponsorsanofi-aventis Groupe
    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 Groupe
    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 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 94 00
    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 Toujeo
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameInsulin glargine
    D.3.2Product code HOE901 - U300
    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 INNINSULIN GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901 - U300
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.2.1.2Country 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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 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
    Type 2 diabetes mellitus
    Diabetes Mellitus Tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Diabetes Mellitus 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 18.0
    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 non-inferiority of Toujeo versus ?standard of care? basal insulin therapy as measured by glycated hemoglobin (HbA1c) change.
    Demostrar la no inferioridad de Toujeo frente a un tratamiento con insulina basal ?de referencia?, determinada en función del cambio en la HbA1c entre el momento basal y el Mes 6.
    E.2.2Secondary objectives of the trial
    ? To demonstrate superiority of Toujeo versus ?standard of care? basal insulin if non-inferiority criterion is met, measured by HbA1c change.
    ? To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
    ? Risk of hypoglycemia including documented, symptomatic hypoglycemia (?70 mg/dL) or severe (according to ADA Working Group).
    ? Change in fasting plasma glucose (FPG).
    ? Change in body weight.
    ? Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).
    ? Change in hypoglycemia control subscale of Treatment Satisfaction Questionnaire (TSQ).
    ? Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
    Superioridad de Toujeo frente a una insulina basal ?de referencia? si se cumple el criterio de no inferioridad, determinada en función del cambio en la HbA1c entre el momento basal y el Mes 6;
    Persistencia del paciente con el tratamiento asignado de insulina basal durante todo el periodo, es decir, desde el inicio hasta el final del ensayo con o sin intensificación;
    Riesgo de hipoglucemia, incluida la hipoglucemia documentada sintomática (? 70 mg/dl) o severa
    Cambio en la HbA1c en el Mes 12;
    Cambio en la glucosa plasmática en ayunas (GPA);
    Cambio en el peso corporal;
    Diferencias en los resultados notificados por el paciente (PRO) medidos a través de las versiones de Estado y Cambio (DTSQs y DTSQc);
    Cambio en la subescala del control Hipoglucémico en el Cuestionario sobre la Satisfacción con el Tratamiento;
    Utilización de recursos sanitarios, incluidas las hospitalizaciones y las visitas a urgencias o a otro profesional sanitario y los costes sanitarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (? 6 months) ?standard of care? basal insulin therapy (including Lantus insulin glargine U100, Levemir, NPH or Tresiba or new basal insulin products including biosimilar) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides) and with or without use of a GLP-1 receptor agonist,
    ? Fasting plasma glucose (FPG) >130 mg/dL (7.2 mmol/L),
    ? Adult patients who have signed an Informed Consent Form (ICF) and privacy form(s).
    ? Se incluirá en este estudio a pacientes con diabetes de tipo 2 controlada de manera insuficiente (hemoglobina glucosilada [HbA1c] >7 %) que sigan (? 6 meses) un tratamiento ?de referencia? con insulina basal (entre las que se incluyen la insulina glargina U100 Lantus, Levemir, PNH, Tresiba u otros productos de insulina basal nuevos, inclusive las biosimilares) con o sin fármacos orales (metformina, SU, tiazolidinedionas, inhibidores de la DPP-4, inhibidores del SGLT-2, glinidas) y con o sin agonistas del receptor del GLP-1;
    ? Glucosa plasmática en ayunas (GPA) > 130 mg/dl (7,2 mmol/l);
    ? Pacientes adultos que hayan firmado un Consentimiento Informado.
    E.4Principal exclusion criteria
    ? HbA1c ?7%, no upper bound,
    ? Age <18 years,
    ? Type 1 diabetes mellitus,
    ? Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient?s successful participation for the duration of the study,
    ? Use of any product containing short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization, (such as Humulin®-R, , Humalog®, Novolog®, Apidra®, Afrezza®, pre-mix insulin and including biosimilar preparation of these products, or other rapid acting insulins which may become available.)
    ? Use of any product containing short or rapid acting insulin occurring within 3 months prior to the time of screening, such as Humulin-R, Humalog, Novolog, Apidra, Afrezza, pre-mix insulin and including biosimilar preparations of these products, or other rapid acting insulins which may become available.)
    ? Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
    ? All contraindications to ?standard of care? insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products.
    ? Pregnancy or lactation,
    ? Women of childbearing potential with no effective contraceptive method.
    Criterios de exclusión relacionados con el diseño del estudio

    ? HbA1c ? 7 %, sin límitesuperior;
    ? Edad < 18 años;
    ? Diabetes mellitus de tipo 1;
    ? Cualquier anomalía clínicamente significativa detectada en la exploración física, las pruebas analíticas o las constantes vitales en el momento de la selección, o cualquier enfermedad sistémica importante que dé lugar a una esperanza de vida corta y que, a juicio del Investigador, pueda restringir o limitar la participación satisfactoria del paciente a lo largo del estudio;
    ? Uso de cualquier producto que contenga insulina de acción corta o rápida desde el momento del diagnóstico de DMT2 que no haya sido para un uso temporal durante un embarazo u hospitalización (como Humulin®-R, Humalog®, Novolog®, Apidra®, Afrezza®, insulina premezclada y productos biosimilares inclusive, o bien otras insulinas de acción rápida que puedan aparecer en el mercado);
    ? Uso de cualquier producto que contenga insulina de acción corta o rápida durante los 3 meses previos al momento de la selección, como Humulin-R, Humalog, Novolog, Apidra, Afrezza, insulina premezclada y preparaciones biosimilares de estos productos, o bien otras insulinas de acción rápida que puedan aparecer en el mercado;
    ? Uso de hipoglucemiantes orales distintos de los indicados entre los criterios de inclusión, agonistas del receptor del GLP-1 no aprobados para su uso con insulina, o cualquier producto en investigación (farmacológico, biológico o dispositivo) durante los 3 meses previos al momento de la selección.


    Criterios de exclusión relacionados con el comparador activo y/o los tratamientos de base obligatorios

    ? Todas las contraindicaciones de los tratamientos de insulina ?de referencia? o las advertencias o precauciones de uso que aparezcan en la ficha técnica nacional de los productos correspondientes.


    Criterios de exclusión relacionados con el conocimiento actual del compuesto de Sanofi

    ? Embarazo o lactancia;
    ? Mujeres en edad fértil que no usan un método anticonceptivo eficaz.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in HbA1c
    Cambio en la HbA1c (%)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to 6 months
    entre el momento basal y el Mes 6.
    E.5.2Secondary end point(s)
    1- Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
    2- Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
    3- Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)
    4- Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (blood glucose [BG] ? 70 mg/dl, [3.9 mmol/L]) symptomatic or severe
    5- Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (BG <54 mg/dl, [3.0 mmol/L]) symptomatic or severe hypoglycemia
    6- Percent change in HbA1c
    7- Percentage of patients whose HbA1c decreased at least 0.5%
    8- Percentage of patients whose HbA1c decreased at least 0.5%
    9- Percentage of patients requiring intensification and time to intensification,
    10- Change in fasting plasma glucose
    1- Proporción de pacientes que continúan con el tratamiento asignado de insulina basal antes de la intensificación (persistentes con el tratamiento asignado)
    2- Proporción de pacientes que continúan con el tratamiento asignado de insulina basal en el Mes 6 y en el Mes 12, tanto si se produce intensificación como si no;
    3- Proporción de pacientes que logran el objetivo de HbA1c de < 6,5 %, < 7 %, < 7,5 %, < 8,0 %) en el Mes 6 y en el Mes 12;
    4- Proporción de pacientes que alcanzan el objetivo de HbA1c (umbrales antes mencionados) (consecución de beneficio metabólico) en el Mes 6 y en el Mes 12 sin hipoglucemia sintomática o severa documentada (glucemia ? 70 mg/dl [3,9 mmol/l]) (según la definición del Grupo de trabajo de la ADA sobre la Hipoglucemia) (1) en cualquier momento del día y de la noche (0:00-5:59);
    5- Proporción de pacientes que alcanzan el objetivo de HbA1c (umbrales antes mencionados) (consecución de beneficio metabólico) en el Mes 6 y en el Mes 12 sin hipoglucemia sintomática o severa documentada (glucemia < 54 mg/dl [3,0 mmol/l]) (según la definición del Grupo de Trabajo de la ADA sobre la Hipoglucemia) (1) en cualquier momento del día y de la noche (0:00-5:59);
    6- Cambio en la HbA1c (%)
    7- Porcentaje de pacientes cuya HbA1c ha descendido al menos un 0,5 %
    8- Porcentaje de pacientes cuya HbA1c ha descendido al menos un 0,5 %
    9- Porcentaje de pacientes que requieren intensificación
    10- Cambio en la glucosa plasmática en ayunas
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 5 : at Month 6 and Month 12
    6 : From baseline to Month 12
    7 : at Month 6 and Month 12
    8 : at Month 6 and maintained at Month 12
    9 : at Month 6 and Month 12
    10 : From baseline to Month 6 and Month 12
    1-5: en el Mes 6 y en el Mes 12;
    6: entre el momento basal y el Mes 12;
    7: en el Mes 6 y en el Mes 12;
    8: al Mes 6 y se ha mantenido al Mes 12;
    9: en el Mes 6 y en el Mes 12, y tiempo transcurrido hasta la intensificación.
    10- entre el momento basal y el Mes 6 y el Mes 12.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA122
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days6
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 580
    F.4.2.2In the whole clinical trial 580
    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 Decision2015-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-20
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