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    Summary
    EudraCT Number:2021-003636-88
    Sponsor's Protocol Code Number:KBP5074-3-001
    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:2022-05-06
    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 number2021-003636-88
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease
    Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la eficacia y la seguridad de KBP-5074, un antagonista del receptor de mineralocorticoides, en sujetos con hipertensión no controlada con nefropatía crónica moderada o grave (estadio IIIb/IV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Efficacy and Safety of KBP-5074, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease
    Estudio para evaluar la eficacia y la seguridad de KBP-5074, en sujetos con hipertensión no controlada con nefropatía crónica moderada o grave (estadio IIIb/IV)
    A.4.1Sponsor's protocol code numberKBP5074-3-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04968184
    A.5.4Other Identifiers
    Name:INDNumber:117743
    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 SponsorKBP BioSciences PTE. Ltd.
    B.1.3.4CountrySingapore
    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 supportKBP BioSciences PTE. Ltd.
    B.4.2CountrySingapore
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKBP BioSciences PTE. Ltd.
    B.5.2Functional name of contact pointKBP Biosciences Clinical Trial Cont
    B.5.3 Address:
    B.5.3.1Street Address80 Robinson Road #02-00
    B.5.3.2Town/ citySingapore
    B.5.3.3Post code068898
    B.5.3.4CountrySingapore
    B.5.4Telephone number1(609) 874-0416
    B.5.6E-mailkbp5074clarion-ckd@kbpbiosciences.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 nameKBP-5074
    D.3.2Product code KBP-5074
    D.3.4Pharmaceutical form Film-coated 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 INNNot available
    D.3.9.1CAS number 1359969-24-6
    D.3.9.2Current sponsor codeKBP-5074
    D.3.9.3Other descriptive nameKBP-5074
    D.3.9.4EV Substance CodeSUB222445
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 nameKBP-5074
    D.3.2Product code KBP-5074
    D.3.4Pharmaceutical form Film-coated 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 INNNot available
    D.3.9.1CAS number 1359969-24-6
    D.3.9.2Current sponsor codeKBP-5074
    D.3.9.3Other descriptive nameKBP-5074
    D.3.9.4EV Substance CodeSUB222445
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboFilm-coated tablet
    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
    Uncontrolled hypertension in patients who have Stage 3b/4 chronic kidney disease
    Hipertensión no controlada con nefropatía crónica moderada o grave (estadio IIIb/IV)
    E.1.1.1Medical condition in easily understood language
    Uncontrolled hypertension in patients who have Stage 3b/4 chronic kidney disease
    Hipertensión no controlada con nefropatía crónica moderada o grave (estadio IIIb/IV)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066860
    E.1.2Term Uncontrolled hypertension
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076410
    E.1.2Term Chronic kidney disease stage 3
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076411
    E.1.2Term Chronic kidney disease stage 4
    E.1.2System Organ Class 100000004857
    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 objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing systolic blood pressure (SBP).
    El objetivo principal de este estudio es evaluar la eficacia y durabilidad de KBP-5074 en la reducción de la presión arterial sistólica (PAS).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the effect of KBP-5074 on diastolic blood pressure (DBP) and urine albumin:creatinine ratio (UACR);
    • To evaluate the safety and tolerability of KBP-5074.
    Los objetivos secundarios de este estudio son los siguientes:
    - Evaluar el efecto de KBP-5074 sobre la presión arterial diastólica (PAD) y el cociente albúmina/creatinina en orina (CACO);
    - Evaluar la seguridad y tolerabilidad de KBP-5074.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject must be ≥18 years of age at the Screening Visit (Visit 1).
    • Body mass index (BMI) must be ≥19 to <45 kg/m2at the Screening Visit (Visit 1).
    • Subject must have uncontrolled hypertension defined as meeting both of the following criteria:
    - The subject has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period.
    - The subject is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3).
    ◦ The antihypertensive medications must include at least 1 loop, thiazide or thiazide-like diuretic unless the subject has a documented intolerance to or contraindication for diuretic therapy.
    ◦ A subject on 1 antihypertensive medication that has been titrated upward as tolerated to a hypertension target dose per local SoC and has been stable during the 4 weeks prior to the Screening Visit (Visit 1) may be enrolled in the study if the subject has a documented history of intolerance to multiple antihypertensive medications.
    • The subject must have Stage 3b (eGFR ≥30 and ≤44 mL/min/1.73 m2) or Stage 4 (eGFR ≥15 and <30 mL/min/1.73 m2) CKD.
    -El sujeto debe tener >/=18 años de edad en la visita de selección (visita 1).
    -El índice de masa corporal (IMC) debe ser de >/=19 a <45 kg/m2 en la visita de selección (visita 1).
    -El sujeto debe presentar hipertensión no controlada, definida como que cumple los dos criterios siguientes:
    --El sujeto tiene una PAS mínima en sedestación en reposo >/=140 mmHg en la visita de selección (visita 1) y al inicio (visita 2) y al final (visita 3) del periodo de preinclusión.
    --El sujeto está tomando 2 o más medicamentos antihipertensivos que se han ajustado al alza en función de la tolerancia a las dosis objetivo para hipertensión según el TE local y se han mantenido estables (es decir, sin ningún ajuste de la dosis) desde 4 semanas antes de la visita de selección (visita 1) hasta el final del periodo de preinclusión (visita 3).
    ---Los medicamentos antihipertensivos deben incluir al menos 1 diurético del asa, tiazídico o de tipo tiazídico, a menos que el sujeto presente intolerancia documentada o contraindicación para el tratamiento diurético.
    ---Un sujeto que esté recibiendo 1 antihipertensor y que se haya ajustado al alza en función de la tolerancia hasta una dosis objetivo para hipertensión según el TE local y que haya permanecido estable durante las 4 semanas anteriores a la visita de selección (visita 1) puede inscribirse en el estudio si el sujeto tiene antecedentes documentados de intolerancia a varios antihipertensivos.
    -El sujeto debe presentar NC en estadio IIIb (TFGe >/=30 y </=44 ml/min/1,73 m2) o estadio IV (TFGe >/=15 y <30 ml/min/1,73 m2).
    E.4Principal exclusion criteria
    Subject has a serum potassium level >4.8 mmol/L according to central laboratory results during the Screening or Run-In Periods.
    • Subject has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1).
    • Subject has been hospitalization for hyperkalemia within the 3 months before the Randomization Visit (Visit 3).
    • Subject was not compliant with taking placebo during the Run-in Period (defined as taking <80% or >120% of planned placebo doses) or the Investigator determines that the subject was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3).
    • Subject has taken an MRA, a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1).
    • Subject has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1).
    • Subject has taken a strong CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3).
    -El sujeto tiene un nivel de potasio sérico >4,8 mmol/l de acuerdo con los resultados del laboratorio central durante los periodos de selección o preinclusión.
    -El sujeto ha tenido un nivel de potasio sérico >5,6 mmol/l en las 2 semanas anteriores a la visita de selección (visita 1).
    -El sujeto ha estado hospitalizado por hiperpotasemia en los 3 meses anteriores a la visita de aleatorización (visita 3).
    -El sujeto no cumplió con la toma de placebo durante el periodo de preinclusión (definido como tomar <80 % o >120 % de las dosis previstas de placebo) o el investigador determina que el sujeto no cumplió con los medicamentos antihipertensivos de base durante el periodo de preinclusión, según se evaluó en la visita de aleatorización (visita 3).
    -El sujeto ha tomado un ARM, un diurético ahorrador de potasio o complementos de potasio crónicos durante las 4 semanas anteriores a la visita de selección (visita 1).
    -El sujeto ha tomado aglutinantes de potasio para el tratamiento de la hiperpotasemia durante los 3 meses anteriores a la visita de selección (visita 1).
    -El sujeto ha tomado un inductor potente de CYP3A4 o un inhibidor potente de CYP3A4 durante los 7 días anteriores a la visita de aleatorización (visita 3).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for efficacy is change in seated trough cuff SBP from baseline to Week 12.
    The second key endpoint for durability is change in seated trough cuff SBP from Week 48 to Week 52.
    El criterio de valoración principal de la eficacia es el cambio en la PAS mínima en sedestación desde el inicio hasta la semana 12.
    El segundo criterio de valoración clave para la durabilidad es el cambio en la PAS mínima en sedestación desde la semana 48 hasta la semana 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12
    From Week 48 to Week 52
    Desde el inicio hasta la semana 12.
    Desde la semana 48 hasta la semana 52.
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints for the study are:
    • Change in seated trough cuff SBP from baseline to Week 24;
    • Changes in seated trough cuff DBP from baseline to Week 12 and Week 24;
    • Changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR ≥30 mg/g at baseline.
    Other secondary efficacy endpoints for the study are:
    • Changes in seated trough cuff SBP and DBP from baseline to Week 48;
    • Percentage changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR ≥30 mg/g at baseline;
    • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline;
    • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline;
    • Change in seated trough cuff DBP from Week 48 to Week 52;
    • Change and percentage change in UACR from Week 48 to Week 52 for subjects with UACR ≥30 mg/g at baseline;
    • Change and percentage change in UACR from Week 48 to Week 52 for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline;
    • Change and percentage change in UACR from Week 48 to Week 52 for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline.
    Safety assessments include evaluation of AEs, vital signs, clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.
    Safety endpoints for this study are:
    • Incidences of SAEs, non-serious AEs, AEs leading to discontinuation of study drug, and AEs leading to discontinuation from the study;
    • Incidences of AEs of hyperkalemia, hypertension, and hypotension;
    • Incidences of serum potassium >5.0 to <5.6 mmol/L, ≥5.6 to <6.0 mmol/L, and ≥6.0 mmol/L by central laboratory results;
    • Changes in serum potassium levels from baseline to Week 12, Week 24, and Week 48 by central laboratory results;
    • Changes in eGFR from baseline to Week 12, Week 24, and Week 48 by central laboratory results;
    • Incidence of sustained decreases in eGFR of ≥30% from baseline by central laboratory results (an eGFR decrease of ≥30% from baseline will be considered sustained if the eGFR reduction is still ≥30% from baseline at least 4 weeks after the initial measurement);
    • Change in serum potassium levels from Week 48 to Week 52 by central laboratory results;
    • Change in eGFR from Week 48 to Week 52 by central laboratory results.
    Los criterios de valoración secundarios clave de la eficacia del estudio son:
    -Cambio en la PAS mínima en sedestación desde el inicio hasta la semana 24;
    -Cambios en la PAD mínima en sedestación desde el inicio hasta la semana 12 y la semana 24;
    -Cambios en el CACO desde el inicio hasta la semana 12 y la semana 24 en los sujetos con CACO >/=30 mg/g al inicio.
    Otros criterios de valoración secundarios de la eficacia del estudio son:
    -Cambio en la PAS y PAD mínima en sedestación desde el inicio hasta la semana 48;
    -Cambios porcentuales en el CACO desde el inicio hasta la semana 12 y la semana 24 para sujetos con CACO >/=30 mg/g al inicio;
    -Cambios y cambios porcentuales en el CACO desde el inicio hasta la semana 12, la semana 24 y la semana 48 para sujetos con macroalbuminuria (definida como CACO >/=300 mg/g) al inicio;
    -Cambios y cambios porcentuales en el CACO desde el inicio hasta la semana 12, la semana 24 y la semana 48 para sujetos con microalbuminuria (definida como CACO ≥30 y <300 mg/g) al inicio;
    -Cambio en la PAD mínima en sedestación desde la semana 48 hasta la semana 52;
    -Cambio y cambio porcentual en el CACO desde la semana 48 hasta la semana 52 para sujetos con CACO >/=30 mg/g al inicio;
    -Cambio y cambio porcentual en el CACO desde la semana 48 hasta la semana 52 en sujetos con macroalbuminuria (definida como CACO >/=300 mg/g) al inicio;
    -Cambio y cambio porcentual en el CACO desde la semana 48 hasta la semana 52 en los sujetos con microalbuminuria (definida como CACO >/=30 y <300 mg/g) al inicio.
    Las evaluaciones de la seguridad incluyen la evaluación de los acontecimientos adversos (AA), las constantes vitales, los hallazgos de los análisis clínicos, los electrocardiogramas (ECG) de 12 derivaciones y los hallazgos de la exploración física.
    Los criterios de valoración de la seguridad para este estudio son:
    -Incidencias de acontecimientos adversos graves (AAG), AA no graves, AA que provoquen la interrupción del fármaco del estudio y AA que provoquen la interrupción de la participación en el estudio;
    -Incidencias de AA de hiperpotasemia, hipertensión e hipotensión;
    -Incidencias de potasio sérico de >5,0 a <5,6 mmol/l, de >/=5,6 a <6,0 mmol/l y >/=6,0 mmol/l según los resultados del laboratorio central;
    -Cambios en los niveles séricos de potasio desde el inicio hasta la semana 12, la semana 24 y la semana 48 según los resultados del laboratorio central;
    -Cambios en la TFGe desde el inicio hasta la semana 12, la semana 24 y la semana 48 según los resultados del laboratorio central;
    -La incidencia de TFGe sostenida >/=30 % con respecto al inicio según los resultados del laboratorio central (una disminución de la TFGe >/=30 % con respecto al inicio se considerará sostenida si la reducción de la TFGe sigue siendo >/=30 % con respecto al inicio al menos 4 semanas después de la medición inicial):
    -Cambio en los niveles séricos de potasio desde la semana 48 hasta la semana 52 según los resultados del laboratorio central;
    -Cambio en la TFGe desde la semana 48 hasta la semana 52 según los resultados del laboratorio central.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Durability, tolerability
    Durabilidad. tolerabilidad
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    China
    Korea, Republic of
    Malaysia
    United States
    Bulgaria
    Netherlands
    Spain
    Czechia
    Germany
    Belgium
    Denmark
    Georgia
    Hungary
    Ukraine
    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
    Último paciente, última visita
    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 months1
    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
    E.8.9.2In all countries concerned by the trial days15
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 405
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 600
    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)
    Standard of care
    Tratamiento estándar
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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