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    Summary
    EudraCT Number:2019-000275-16
    Sponsor's Protocol Code Number:2693-CL-0304
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-000275-16
    A.3Full title of the trial
    A Randomized, Placebo-controlled, Double-blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering from Vasomotor Symptoms (Hot Flashes) Associated with Menopause
    Estudio clínico de fase III aleatorizado, controlado con placebo y con doble enmascaramiento para investigar la seguridad a largo plazo del fezolinetant en mujeres con síntomas vasomotores (sofocos) asociados a la menopausia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to Assess the Safety of Fezolinetant in Women Suffering from Hot Flashes Associated with Menopause
    Ensayo para evaluar la seguridad del fezolinetant en mujeres que padecen sofocos asociados a la menopausia
    A.3.2Name or abbreviated title of the trial where available
    Skylight 4
    A.4.1Sponsor's protocol code number2693-CL-0304
    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 SponsorAstellas Pharma Global Development, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V. - Clinical Trial Unit
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3171545 5878
    B.5.5Fax number+3171545 5224
    B.5.6E-mailctu@astellas.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 nameFezolinetant
    D.3.2Product code ESN364
    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 INNFEZOLINETANT
    D.3.9.1CAS number 1629229-37-3
    D.3.9.2Current sponsor codeESN364
    D.3.9.4EV Substance CodeSUB188609
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 nameFezolinetant
    D.3.2Product code ESN364
    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 INNFEZOLINETANT
    D.3.9.1CAS number 1629229-37-3
    D.3.9.2Current sponsor codeESN364
    D.3.9.4EV Substance CodeSUB188609
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFEZOLINETANT
    D.3.9.1CAS number 1629229-37-3
    D.3.9.2Current sponsor codeESN364
    D.3.9.4EV Substance CodeSUB188609
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Vasomotor Symptoms (Hot Flashes) Associated with Menopause
    Síntomas vasomotores (sofocos) asociados a la menopausia
    E.1.1.1Medical condition in easily understood language
    Hot Flashes Associated with Menopause
    Sofocos asociados a la menopausia
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020407
    E.1.2Term Hot flashes
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of fezolinetant in women seeking treatment for relief of Vasomotor Symptoms (VMS) associated with menopause.
    Evaluar la tolerabilidad y la seguridad a largo plazo del fezolinetant en mujeres que buscan tratamiento para aliviar los síntomas vasomotores (SVM) asociados a la menopausia.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of fezolinetant on endometrial health after long-term treatment in women
    seeking treatment for relief of VMS associated with menopause.
    Evaluar el efecto del fezolinetant en la salud endometrial tras el tratamiento a largo plazo en mujeres que buscan tratamiento para aliviar los SVM asociados a la menopausia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is born female, aged ≥ 40 years and ≤ 65 years of age at the screening visit.
    3. Subject has a body mass index between ≥18 kg/m2 and ≤ 38 kg/m2.
    4. Subject must be seeking treatment or relief for VMS associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:
    ● Spontaneous amenorrhea for ≥ 12 consecutive months
    ● Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (FSH > 40 IU/L), or
    ● Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit (with or without hysterectomy).
    5. Subject is seeking treatment for relief for VMS associated with menopause.
    6. Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters; pulse rate and/or blood pressure; and ECG within the reference range for the population studied, or showing no clinically relevant deviations, as judged by the investigator.
    7. Subject has documentation of a normal/negative or no clinically significant mammogram findings (obtained at screening or within the prior 12 months of trial enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.
    8. Subject is willing to undergo a TVU to evaluate the uterus and ovaries at screening and at week 52 (EOT). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the ED visit. This is not required for subjects who have had a partial (supra-cervical) or full hysterectomy.
    9. Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT) or the ED visit for subjects who are withdrawn from the study prior to completion, andny time during the study in the case of uterine bleeding. This is not required for subjects who have had a partial (supracervical) or full hysterectomy.
    10. Subject has documentation of a normal or not clinically significant Pap test (or
    equivalent cervical cytology) in the opinion of the investigator within the previous
    9 months or at screening.
    11. Subject has a negative urine pregnancy test at screening.
    12. Subject has a negative serology panel (i.e., negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.
    13. Subject agrees not to participate in another interventional study while participating in the present study.
    1. Antes de que se lleve a cabo cualquier procedimiento relacionado con el estudio (incluida la retirada de los medicamentos prohibidos, si procede) la paciente o su representante legal deberán firmar un consentimiento informado por escrito, aprobado por el comité de ética independiente, y el texto sobre privacidad conforme con la normativa local.
    2. La paciente ha nacido siendo mujer, y tiene una edad ≥ 40 años y ≤ 65 años en la visita de selección.
    3. La paciente tiene un índice de masa corporal ≥ 18 kg/m2 y ≤ 38 kg/m2.
    4. La paciente debe estar buscando tratamiento o alivio para los SVM asociados a la menopausia y tener menopausia confirmada por 1 de los
    siguientes criterios en la visita de selección:
    ● Amenorrea espontánea durante ≥12 meses consecutivos
    ● Amenorrea espontánea durante ≥6 meses con criterios bioquímicos de menopausia (concentraciones de hormona foliculoestimulante > 40UI/l), o
    ● Haberse sometido a una ooforectomía bilateral ≥ 6 semanas antes de la visita de selección (con o sin histerectomía).
    5. La paciente está buscando tratamiento para aliviar los SVM asociados a la menopausia.
    6. La paciente goza de buen estado de salud general, determinado a partir de la anamnesis y la exploración física general, incluyendo una exploración pélvica clínica bimanual y una exploración clínica de mama carentes de hallazgos clínicos relevantes, realizados en la visita de selección; parámetros de hematología y bioquímica; frecuencia de pulso y/o presión arterial; y ECG dentro del rango de referencia para la población estudiada, o sin mostrar ninguna desviación clínicamente relevante, a criterio del investigador.
    7. La paciente tiene documentación de resultados de mamografía que son normales/negativos o no clínicamente significativos (obtenidos en la selección o en los 12 meses previos a la inclusión en el ensayo). La documentación adecuada incluye un informe escrito o un informe
    electrónico que indique resultados de mamografía normales/negativos o no clínicamente significativos.
    8. La paciente está dispuesta a someterse a una ETV para evaluar el útero y los ovarios en la selección y en la semana 52 (FdT). En el caso de las pacientes que se retiren del estudio antes de su finalización, se realizará una ETV en la visita de IA. Esto no es necesario para las pacientes que se hayan sometido a una histerectomía parcial (supracervical) o completa.
    9. La paciente está dispuesta a someterse a una biopsia endometrial en la visita de selección y en la semana 52 (FdT) o en la visita de IA en el
    caso de aquellas pacientes que se retiren del estudio antes de su finalización, y en cualquier momento durante el estudio en caso de sangrado uterino. Esto no es necesario para las pacientes que se hayan sometido a una histerectomía parcial (supracervical) o completa.
    10. La paciente tiene documentación de una prueba de Papanicolaou (o citología cervical equivalente) normal o no clínicamente significativa a criterio del investigador en los 9 meses anteriores o en la selección.
    11. La paciente tiene una prueba de embarazo en orina negativa en la selección.
    12. La paciente tiene un perfil serológico negativo (es decir, resultado negativo para el antígeno de superficie de la hepatitis B, para el
    anticuerpo contra el virus de la hepatitis C y para el anticuerpo contra el virus de inmunodeficiencia humana) en la selección.
    13. La paciente acepta no participar en otro estudio de intervención mientras participe en el presente estudio.
    E.4Principal exclusion criteria
    1. Subject uses a prohibited therapy (strong or moderate CYP1A2 inhibitors, HRT, hormonal contraceptive, any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue such drugs for the full extent of the study.
    2. Subject has a known substance abuse or alcohol addiction within 6 months of screening, as assessed by investigator.
    3. Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.
    4. Subject has hypertension defined as systolic blood pressure ≥ 130 mmHg or diastolic blood pressure as ≥ 80 mmHg based on an average of 2 to 3 readings at screening and randomization.
    Subjects with a medical history with hypertension who are well controlled may be enrolled at the discretion of the investigator.
    5. Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
    6. For subjects with a uterus: Subject has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.
    7. For subjects with a uterus: Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer or other clinically significant findings in the opinion of the investigator at screening. A biopsy with insufficient material for evaluation or unevaluable material is acceptable provided the endometrial thickness is < 4 mm.
    8. Subject has a history within the last 6 months of undiagnosed uterine bleeding.
    9. Subject has a history of seizures or other convulsive disorders.
    10. Subject has a medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome in the opinion of the investigator.
    11. Subject has active liver disease, jaundice, elevated liver aminotransferases (ALT or AST), elevated total or direct bilirubin (DBL), elevated International Normalized Ratio (INR), or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to < 1.5 × the upper limit of normal (ULN) can be enrolled if total and DBL are normal. Patients with mildly elevated ALP (up to < 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert’s syndrome with elevated TBL may be enrolled as long as DBL,
    hemoglobin, and reticulocytes are normal.
    12. Subject has creatinine > 1.5 × ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula ≤ 59 mL/min per 1.73 m2 at the screening visit.
    13. Subject has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of “yes” to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale [C-SSRS]), or who is at significant risk to commit suicide, as assessed by the investigator at screening and at the time of visit 2 (randomization).
    1. La paciente utiliza un tratamiento prohibido (inhibidores potentes o moderados del citocromo P450 [CYP] 1A2, terapia de reemplazo hormonal [TRH], anticonceptivo hormonal, cualquier tratamiento para los SVM [con receta, sin receta o a base de plantas]) o no está dispuesta a someterse a un período de reposo farmacológico e interrumpir el tratamiento con estos fármacos durante todo el estudio.
    2. La paciente tiene antecedentes conocidos de drogodependencia o alcoholismo en los 6 meses previos a la selección, determinado por la evaluación del investigador.
    3. La paciente tiene antecedentes previos o actuales de un tumor maligno, a excepción del carcinoma basocelular.
    4. La paciente tiene hipertensión, definida como presión arterial sistólica ≥ 130 mmHg o presión arterial diastólica ≥ 80 mmHg basada en la media
    de 2 a 3 lecturas en la selección y la aleatorización. Las pacientes con antecedentes médicos de hipertensión que estén bien controladas pueden incluirse a criterio del investigador.
    5. La paciente tiene antecedentes de alergia severa, hipersensibilidad o intolerancia a los fármacos en general, incluyendo el fármaco del studio y cualquiera de sus excipientes.
    6. En el caso de pacientes con útero: La paciente obtiene un resultado inaceptable en la ETV en la selección, es decir, la longitud total de la
    cavidad endometrial no se puede visualizar o hay presencia de un hallazgo clínicamente significativo.
    7. En el caso de pacientes con útero: La paciente tiene una biopsia endometrial que confirma la presencia de endometrio proliferativo desordenado, hiperplasia endometrial, cáncer endometrial u otros hallazgos clínicamente significativos a criterio del investigador en la selección. Una biopsia con material insuficiente para la evaluación o material no evaluable es aceptable siempre que el espesor endometrial sea < 4 mm.
    8. La paciente tiene antecedentes en los 6 últimos meses de sangrado uterino no diagnosticado.
    9. La paciente tiene antecedentes de convulsiones u otros trastornos convulsivos.
    10. La paciente tiene una dolencia o enfermedad crónica (incluyendo antecedentes de enfermedad neurológica [incluyendo cognitiva], hepática, renal, cardiovascular, gastrointestinal, pulmonar [p. ej., asma moderada], endocrina o ginecológica) o neoplasia maligna que en opinión del investigador podría confundir la interpretación del resultado del estudio.
    11. La paciente tiene enfermedad hepática activa, ictericia, niveles elevados de aminotransferasas hepáticas (ALT o AST), de bilirrubina total, del cociente internacional normalizado (CIN) o de fosfatasa alcalina (FA). Las pacientes con niveles ligeramente elevados de ALT o AST hasta < 1,5 × límite superior de la normalidad (LSN) pueden incluirse si los niveles de bilirrubina total y directa (BD) son normales. Las pacientes con niveles ligeramente elevados de FA (hasta < 1,5 × LSN) pueden incluirse si se descarta la existencia de enfermedad hepática colestásica y no se diagnostica ninguna causa que no sea hígado graso. Las pacientes con síndrome de Gilbert con niveles elevados de bilirrubina total (BT) pueden incluirse mientras los niveles de BD, hemoglobina y reticulocitos sean normales.
    12. La paciente tiene creatinina > 1,5×LSN; o la tasa de filtración glomerular estimada utilizando la fórmula de modificación de la dieta en la enfermedad renal es ≤59 ml/min por 1,73 m2 en la visita de selección.
    13. La paciente tiene antecedentes de intento de suicidio o comportamiento suicida en los últimos 12 meses o tiene ideación suicida en los últimos 12 meses (una respuesta afirmativa a las preguntas 4 o 5 de la parte de ideación suicida de la Escala Columbia para evaluar el riesgo de suicidio [Columbia-Suicide Severity Rating Scale, C-SSRS]), o tiene un riesgo significativo de suicidarse, según lo evaluado por el investigador en la selección y en el momento de la visita 2 (aleatorización).
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoint:
    ● Frequency and severity of AEs
    Criterio de valoración para la seguridad:
    • Frecuencia e intensidad de los acontecimientos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    This end point is the overall frequency and severity of AEs over the full course of the study. AEs are evaluated at each visit but it will be the frequency across the full 12 month study that will be evaluated for the primary endpoint.
    Este criterio de valoración evalúa la frecuencia e intensidad de los acontecimientos adversos en el transcurso del estudio. Se evalúan los acontecimientos adversos en cada visita, pero será la frecuencia durante los 12 meses completos del estudio lo que se evaluará para el criterio de
    valoración principal.
    E.5.2Secondary end point(s)
    ● Change from baseline in endometrial thickness at 12 months.
    ● Percentage of subjects with endometrial hyperplasia and/or endometrial cancer.
    ● Change from baseline in bone mass density (BMD) and trabecular bone score (TBS) hip and spine at 12 months.
    ● Vital signs: sitting systolic and diastolic blood pressure and pulse rate.
    ● Laboratory tests: hematology, biochemistry and urinalysis.
    ● C-SSRS.
    ● ECG parameters.
    • Cambio desde el inicio en el grosor del endometrio a los 12 meses
    • Porcentaje de pacientes con hiperplasia endometrial y/o cáncer endometrial
    • Cambio desde el inicio en la puntuación de la densidad de masa ósea y del hueso trabecular en la cadera y la columna vertebral a los 12 meses
    • Constantes vitales: pulso, presión arterial sistólica y diastólica en sedestación
    • Pruebas analíticas: hematología, bioquímica y análisis de orina
    • C-SSRS
    • Parámetros del ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endometrial thickness and BMD/TBS assessments are done at baseline and EOT/12 months.
    Other secondary points are evaluated at each visit.
    Las evaluaciones del espesor endometrial y de la densidad de masa ósea/hueso trabecular se realizan en el inicio y en el mes 12/FdT. Se evalúan otros criterios de valoración secundarios en cada visita.
    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 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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Canada
    Czech Republic
    Germany
    Hungary
    Latvia
    Poland
    Romania
    Spain
    Ukraine
    United Kingdom
    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 (última visita del último paciente)
    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: 1149
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 317
    F.4.2.2In the whole clinical trial 1149
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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