Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000420-95
    Sponsor's Protocol Code Number:THR-1442-C-423
    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:2017-05-29
    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 number2017-000420-95
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Effects of Bexagliflozin versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
    Estudio en fase 3, aleatorizado, controlado con elemento activo, doble ciego para evaluar los efectos de bexagliflozina en comparación con sitagliptina en sujetos con diabetes mellitus tipo 2 que tienen un control glucémico inadecuado con metformina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with poorly controlled type 2 diabetes to compare the effectiveness of bexagliflozin with sitagliptin
    Ensayo clínico en pacientes con diabetes tipo 2 mal controlada para comparar la efectividad de la bexagliflozina con sitagliptina
    A.4.1Sponsor's protocol code numberTHR-1442-C-423
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03115112
    A.5.4Other Identifiers
    Name:EMANumber:UPI number 498543
    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 SponsorTheracos Sub, LLC
    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 supportTheracos Sub, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTranslational Medicine Group - MGH
    B.5.2Functional name of contact pointClinical Trial Project Management
    B.5.3 Address:
    B.5.3.1Street AddressMassachusetts General Hospital, 185 Cambridge Street
    B.5.3.2Town/ cityBoston, MA
    B.5.3.3Post codeMA 02114
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016177264236
    B.5.5Fax number0016176438203
    B.5.6E-mailinfo@theracos.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 nameBexagliflozin
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEXAGLIFLOZIN
    D.3.9.1CAS number 1118567-05-7
    D.3.9.3Other descriptive nameTHR1442
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Sitagliptin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSitagliptin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSITAGLIPTIN
    D.3.9.1CAS number 486460-32-6
    D.3.9.4EV Substance CodeSUB25227
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes Mellitus Type 2
    Diabetes Mellitus Tipo 2
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabetes
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.2System Organ Class 100000004861
    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 efficacy objective of this trial is to demonstrate that bexagliflozin is non-inferior to sitagliptin by evaluating the treatment effect on HbA1c reduction at week 24 in subjects whose T2DM is inadequately controlled by metformin.
    El objetivo principal de eficacia de este ensayo es demostrar que bexagliflozina no es inferior a sitagliptina mediante la evaluación del efecto del tratamiento sobre la reducción de la hemoglobina A1c (HbA1c) en la semana 24 en sujetos con DMT2 no controlada adecuadamente con metformina.
    E.2.2Secondary objectives of the trial
    •To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in fasting plasma glucose (FPG) at week 24
    •To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in body weight in subjects with baseline body mass index (BMI) ≥ 25 kg/m2 at week 24
    •To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in systolic blood pressure (SBP) in subjects at week 24
    • Evaluar el efecto del tratamiento con bexagliflozina en comparación con sitagliptina sobre el cambio en la glucemia plasmática en ayunas (GPA) en la semana 24
    • Evaluar el efecto del tratamiento con bexagliflozina en comparación con sitagliptina sobre el cambio en el peso corporal en sujetos con un índice de masa corporal (IMC) basal ≥25 kg/m2 en la semana 24
    • Evaluar el efecto del tratamiento con bexagliflozina en comparación con sitagliptina sobre el cambio en la presión arterial sistólica (PAS) en los sujetos en la semana 24
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female adult subjects ≥ 18 years of age
    2.If subjects are female of childbearing potential, subjects must be negative on the urine pregnancy test and agree to abstain from coitus or use contraception during the entire study
    3.Subjects with a diagnosis of T2DM with HbA1c levels between 7.0% and 11% (inclusive) at screening
    4.Subjects whose T2DM is treated with a stable dose of ≥ 1500 mg/day metformin only along with diet and exercise counseling for at least 8 weeks prior to screening
    5.Subjects have a BMI ≤ 45 kg/m2 at screening
    6.If applicable, taking stable doses of treatment for dyslipidemia and/or hypertension for 30 days prior to screening
    7.Subjects who are willing and able to return for all clinic visits and to complete all study-required procedures, including SMBG measurements
    Prior to randomization, all subjects must:
    8.Adhere to the investigational product administration requirements as evidenced by missing no more than 1 day of run-in medications. If run-in medication doses are missed for reasons that, in the judgement of the investigator, are appropriate, this requirement may be waived
    1. Sujetos adultos de ambos sexos de ≥18 años de edad.
    2. Si los sujetos son mujeres en edad fértil, deberán tener un resultado negativo en la prueba de embarazo en orina y aceptar abstenerse de practicar el coito o utilizar métodos anticonceptivos durante todo el estudio
    3. Sujetos con un diagnóstico de DMT2 y niveles de HbA1c entre el 7,0 y el 11 % (ambos inclusive) en la selección.
    4. Sujetos que estén recibiendo tratamiento para la DMT2 con una dosis estable de ≥1500 mg/día de metformina solo, además de asesoramiento sobre dieta y ejercicio, durante al menos 8 semanas antes de la selección.
    5. Sujetos con un IMC ≤45 kg/m2 en la selección.
    6. Si procede, estar tomando dosis estables de tratamiento para la dislipidemia y/o la hipertensión durante 30 días antes de la selección.
    7. Sujetos con voluntad y capacidad para acudir a todas las visitas al centro y completar todos los procedimientos que exige el estudio, incluidas las medidas de autoseguimiento de la glucosa en sangre (ASGS).

    Antes de la aleatorización, todos los sujetos deben:
    8. Cumplir con los requisitos de administración del producto en investigación, demostrado mediante la omisión de no más de 1 día de las medicaciones de preinclusión. Si no se toman las dosis de medicamentos de preinclusión por razones que, a juicio del investigador, son apropiadas, no se exigirá este requisito.
    E.4Principal exclusion criteria
    1.Diagnosis of type 1 diabetes mellitus or maturity–onset diabetes of the young (MODY)
    2.Hemoglobinopathy that affects HbA1c measurement
    3.Any contraindication to the safe use of DPP4 therapy or sitagliptin, including known hypersensitivity reaction
    4.History of pancreatitis
    5.Genitourinary tract infection within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from screening
    6.Cancer, active or in remission, for < 3 years (non-melanoma skin cancer or basal cell carcinoma or carcinoma in situ of the cervix will not be grounds for exclusion)
    7.History of alcohol or illicit drug abuse in the past 2 years
    8.Triglycerides > 500 mg/dl at Visit V1
    9.Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase > 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert’s syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN
    10.eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), < 60 mL/min/1.73 m2 at screening.
    11.Uncontrolled hypertension (SBP > 160 mmHg or diastolic BP > 95 mmHg) at Visit V1
    12.Life expectancy < 2 years
    13.History of MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
    14.History of treatment with an investigational drug within 30 days or within 7 half-lives of the investigational drug, whichever is longer
    15.Previous treatment with bexagliflozin or EGT0001474 study drug (run-in or double-blind investigational product)
    16.Currently or within 3 months of taking any SGLT2 inhibitor
    17.Currently participating in another interventional trial
    18.Prior renal transplantation or evidence of nephrotic syndrome (defined as a urine albumin-to-creatinine ratio (UACR) > 1500 mg/g at screening).
    19.Any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject’s appropriate participation in this study or obscure the effects of treatment
    20.Female subjects who are pregnant or nursing
    21.Two or more consecutive SMBG measures ≥ 250 mg/dL (13.9 mmol/L) prior to randomization accompanied by clinical signs or symptoms of hyperglycemia prior to randomization, including weight loss, blurred vision, increased thirst, increased urination, or fatigue
    1. Diagnóstico de diabetes mellitus tipo 1 o diabetes del adulto de instauración juvenil (MODY, por sus siglas en inglés)
    2. Hemoglobinopatía que afecta a la medición de HbA1c
    3. Cualquier contraindicación del uso seguro de terapia con DPP4 o sitagliptina, incluida reacción de hipersensibilidad conocida
    4. Antecedentes de pancreatitis
    5. Infección del tracto genitourinario dentro de las 6 semanas previas a la selección o antecedentes de ≥3 infecciones genitourinarias que requieran tratamiento en los 6 meses previos a la selección
    6. Cáncer, activo o en remisión, durante <3 años (el cáncer de piel no melanoma, el carcinoma basocelular o el carcinoma in situ del cuello del útero no serán motivo de exclusión)
    7. Antecedentes de abuso de alcohol o drogas ilícitas en los últimos 2 años
    8. Triglicéridos >500 mg/dl en la visita V1
    9. Indicios de resultados anómalos en las pruebas de función hepática (bilirrubina total o fosfatasa alcalina >1,5 veces el límite superior normal [LSN] con la excepción del síndrome de Gilbert aislado); o alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >2,5 veces el LSN
    10. TFGe, calculada según la ecuación derivada del estudio de modificación de la dieta en la enfermedad renal (MDRD), <60 ml/min/1,73 m2 en la selección
    11. Hipertensión no controlada (PAS >160 mmHg o PA diastólica >95 mmHg) en la visita V1
    12. Esperanza de vida <2 años
    13. Antecedentes de IM, angina inestable, ictus u hospitalización por insuficiencia cardíaca en los 3 meses previos a la selección
    14. Antecedentes de tratamiento con un fármaco en investigación en los últimos 30 días o 7 semividas del fármaco en investigación, lo que sea más largo
    15. Tratamiento previo con bexagliflozina o con el fármaco del estudio EGT0001474 (producto en investigación de preinclusión o doble ciego)
    16. Uso en la actualidad o en los últimos 3 meses de cualquier inhibidor de SGLT2
    17. Participación en la actualidad en otro ensayo clínico intervencionista
    18. Trasplante renal previo o signos de síndrome nefrótico (definido como un cociente albúmina/creatinina en orina [UACR, por sus siglas en inglés] >1500 mg/g en la selección)
    19. Cualquier afección, enfermedad, trastorno o anomalía clínicamente relevante que, en opinión del investigador principal, pudiera comprometer la adecuada participación del sujeto en este estudio u ocultar los efectos del tratamiento
    20. Mujeres embarazadas o en periodo de lactancia
    21. Dos o más medidas consecutivas de ASGS ≥250 mg/dl (13,9 mmol/l) antes de la aleatorización acompañadas de signos o síntomas clínicos de hiperglucemia antes de la aleatorización, incluido pérdida de peso, visión borrosa, aumento de la sed, aumento de la frecuencia de micción o fatiga
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c from baseline at week 24
    Cambio en la HbA1c respecto al valor basal en la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Fasting plasma glucose measurement at baseline and week 24.
    Medición de la glucemia plasmática en ayunas en el valor basal y en la semana 24.
    E.5.2Secondary end point(s)
    •Change in FPG from baseline at week 24
    •Change in body weight in subjects with baseline BMI ≥ 25 kg/m2 at week 24
    •Change in SBP in subjects from baseline at week 24
    • Cambio en la GPA respecto al valor basal en la semana 24
    • Cambio en el peso corporal en sujetos con un índice de masa corporal (IMC) basal ≥25 kg/m2 en la semana 24
    • Cambio en la PAS en los sujetos respecto al valor basal en la semana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    FPG measurement at week 24
    Body weight in subjects with baseline BMI ≥ 25 kg/m2 measurement at week 24
    SBP measurement at week 24
    Medición de la GPA en la semana 24
    Medición del peso corporal en sujetos con un IMC basal ≥25 kg/m2 en la semana 24
    Medición de la PAS en la semana 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other 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 Yes
    E.8.2.3.1Comparator description
    Sitagliptin
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Czech Republic
    Hungary
    Poland
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 374
    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, only safety FUP when the Patient is still in the Trial but has ended Treatment Phase.
    Ninguno, sólo seguimiento de seguridad cuando el paciente todavía está en el ensayo, pero ha terminado la Fase de Tratamiento.
    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 Decision2017-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 19:47:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA