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    Summary
    EudraCT Number:2014-000226-38
    Sponsor's Protocol Code Number:156-13-210
    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:2014-10-16
    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 number2014-000226-38
    A.3Full title of the trial
    A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
    Ensayo de fase 3b, multicéntrico, con retirada aleatorizada, controlado con placebo, doble ciego, de grupos paralelos para comparar la eficacia y seguridad de tolvaptán (de 45 a 120 mg/día en dosis dividida) en sujetos con enfermedad renal crónica de estadio 2 avanzado a estadio 4 precoz causada por enfermedad renal poliquística autosómica dominante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease
    Este es un estudio para evaluar la seguridad y eficacia de Tolvaptan en adultos con déficit de la función renal
    A.4.1Sponsor's protocol code number156-13-210
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02160145
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointOlga Sergeyeva, MD, MPH
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville,
    B.5.3.3Post codeMaryland 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number1-609-249-6643
    B.5.5Fax number1-609-249-0643
    B.5.6E-mailolga.sergeyeva@otsuka-us.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1175
    D.3 Description of the IMP
    D.3.1Product nameTolvaptan 15mg
    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 INNTolvaptan
    D.3.9.2Current sponsor codeOPC-41061
    D.3.9.4EV Substance CodeSUB31691
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1175
    D.3 Description of the IMP
    D.3.1Product nameTolvaptan 30mg
    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 INNTolvaptan
    D.3.9.2Current sponsor codeOPC-41061
    D.3.9.4EV Substance CodeSUB31691
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Enfermedad renal poliquística autosómica
    dominante
    E.1.1.1Medical condition in easily understood language
    ADPKD is an inherited condition (passed from ones parents) that causes cysts (fluid filled sacs) to develop on the kidneys. It causes the kidneys to get bigger over time and for the kidneys to fail.
    (PQRAD), una afección hereditaria que produce la destrucción progresiva de la estructura normal del riñón y da lugar a una enfermedad renal terminal (ERT).
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of tolvaptan treatment in
    reducing the change in estimated glomerular filtration rate
    (eGFR) from pre-treatment baseline to post-treatment followup,
    as compared with placebo, in subjects with late-stage
    chronic kidney disease (CKD) due to ADPKD who tolerate
    tolvaptan during an initial run-in period.
    Comparar la eficacia del tratamiento entre tolvaptán y placebo en
    la reducción del cambio de la tasa de filtración glomerular estimada (TFGe) entre la línea inicial pretratamiento y el seguimiento postratamiento, en sujetos con enfermedad renal crónica (ERC) avanzada por PQRAD que toleran tolvaptán durante un periodo de preinclusión inicial.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of tolvaptan treatment in
    reducing the decline of annualized eGFR slope, as compared
    with placebo, in subjects with late-stage CKD due to ADPKD
    who tolerate tolvaptan during an initial run-in period.
    To compare overall and hepatic safety of tolvaptan with
    placebo and to compare incidence of ADPKD complications
    (outcomes) during the trial.
    Comparar la eficacia del tratamiento entre tolvaptán y placebo
    en la reducción del descenso de la pendiente de la TFGe anualizada, en
    pacientes con ERC avanzada por PQRAD que toleran tolvaptán durante un periodo de preinclusión inicial.
    Comparar la seguridad global y hepática entre tolvaptán y placebo y
    comparar la incidencia de complicaciones de la PQRAD (resultados) durante el ensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects age 18 to 55 years of age (inclusive) with eGFR between 25 and 65
    mL/min/1.73m2 -OR-
    2. Male and female subjects age 56 to < 66 years of age with eGFR between 25 and
    44 mL/min/1.73m2 (by medical monitor discretion, only).
    3. Male and female subjects who are tolvaptan naïve.
    4. Diagnosis of ADPKD by modified Pei-Ravine criteria18 19:
    - with family history: several cysts per kidney (3 if by sonography, 5 if by CT or MRI)
    - without family history: 10 cysts per kidney (by any radiologic method, above) and exclusion
    of other cystic kidney diseases. Conditions to be excluded include: multiple simple renal
    cysts, renal tubular acidosis, cystic dysplasia of the kidney, multicystic kidney, multilocular
    cysts of the kidney, medullary cystic kidney and acquired cystic disease of the kidney.
    - Distribution and number of cysts consistent with the observed level of renal function deficit
    1. Varones y mujeres de 18 a 55 años de edad (ambos inclusive) con una TFGe entre 25 y 65
    ml/min/1,73 m2 -O-
    2. Varones y mujeres de 56 a < 66 años de edad con una TFGe entre 25 y 44 ml/min/1,73 m2 (según el criterio del supervisor médico exclusivamente).
    3. Varones y mujeres no tratados anteriormente con tolvaptán.
    4. Diagnóstico de PQRAD según los criterios modificados de Pei-Ravine18, 19:
    ? Con antecedentes familiares: varios quistes en cada riñón (3 si se evalúan mediante ecografía, 5 si se visualizan mediante TC o RM).
    ? Sin antecedentes familiares: 10 quistes en cada riñón (visualizados mediante cualquiera de los métodos radiológicos mencionados anteriormente) y exclusión de otras enfermedades renales quísticas. Entre los trastornos a excluir se encuentran: múltiples quistes simples del riñón, acidosis tubular renal, displasia renal quística, poliquistosis renal, quistes multiloculares renales, nefropatía quística medular y enfermedad renal quística adquirida.
    ? Distribución y número de quistes coherentes con el grado observado de déficit de la función renal.
    E.4Principal exclusion criteria
    1. Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If
    employing birth control, 2 of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control depot injection, condom, or sponge with spermicide.
    2. Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
    3. Need for chronic diuretic use.
    4. Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease during the pre-randomization period.
    5. Subjects with advanced diabetes (eg, glycosylated hemoglobin [HgbA1c] > 7.5, and/or glycosuria by dipstick, significant proteinuria, retinopathy), evidence of additional significant renal
    disease(s) (ie, currently active glomerular nephritidies), renal cancer, single kidney, or recent (within last 6 months) renal surgery or acute kidney injury.
    6. Subjects with contraindications to required trial assessments.
    7. Subjects who, in the opinion of the trial investigator or medical monitor, have a medical history or medical findings inconsistent with safety or compliance with trial assessments.
    1. Mujeres en edad fértil (MEF) que no acepten utilizar 2 métodos anticonceptivos diferentes o no mantener relaciones sexuales durante el ensayo y los 30 días posteriores a la última dosis del PEI. Si emplean un método anticonceptivo, deben utilizarse 2 de las siguientes precauciones: vasectomía del compañero, ligadura de las trompas, diafragma vaginal, dispositivo intrauterino, píldora anticonceptiva, implante anticonceptivo, inyección anticonceptiva depot, preservativo o esponja con espermicida.
    2. Mujeres en periodo de lactancia y/o con resultado positivo en un test de embarazo antes de recibir el PEI.
    3. Necesidad de uso crónico de diuréticos.
    4. Alteración hepática o anomalías de la función hepática diferentes a la esperada por una PQRAD, con típica enfermedad hepática quística, durante el periodo previo a la aleatorización.
    5. Los sujetos con diabetes avanzada (p. ej., hemoglobina glicosilada [HgbA1c] > 7,5, y/o glucosuria en tira reactiva, proteinuria importante, retinopatía), evidencia de enfermedad o enfermedades renales importantes adicionales (es decir, glomerulonefritis actualmente activa), cáncer renal, riñón único, cirugía renal reciente (en los últimos 6 meses) o lesión renal aguda.
    6. Sujetos con contraindicaciones a las evaluaciones necesarias del ensayo.
    7. Sujetos que, en opinión del investigador del ensayo o del supervisor médico, tienen un historial médico o hallazgos médicos contradictorios de seguridad o del cumplimiento de las evaluaciones del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment difference in the change of eGFR from pre-treatment baseline to posttreatment
    follow-up, annualized (divided) by each subjects IMP treatment duration.
    La diferencia del tratamiento en el cambio de la TFGe entre condiciones iniciales
    pretratamiento y el seguimiento postratamiento, anualizado (dividido) según la duración
    del tratamiento con el PEI en cada sujeto
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study up to the Follow up period (3 week post treatment end). The eGFR values will be calculated from the central-laboratory serum creatinine concentrations taken at screening and during every trial visit including follow up visit.
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoint
    Treatment difference in annualized slope of eGFR calculated for individual subjects using an appropriate baseline and available, post-randomization, on-treatment assessments.
    Safety Endpoints
    Safety endpoints to be analyzed will include a descriptive summary of:
    1)AEs
    2)Vital signs
    3)Clinical laboratory tests, including serum transaminases, BT, ALP, and serum sodium
    Pharmacokinetic/Pharmacodynamic Endpoints
    PK Endpoints: Determination of plasma tolvaptan and metabolite(s), including DM-4103 concentrations.
    PD Endpoints: Uosm and urine specific gravity
    Criterio de valoración secundario clave de la eficacia:
    Diferencia del tratamiento en la pendiente de la TFGe anualizada y calculada para los sujetos individuales, usando evaluaciones iniciales apropiadas y las disponibles con tratamiento tras la aleatorización.
    Criterios de valoración de la seguridad:
    1) AA
    2) Constantes vitales
    3) Pruebas de laboratorio clínico, incluidas transaminasas séricas, bilirrubina total (BT), fosfatasa alcalina (FA) y sodio sérico
    Criterios de valoración FC: Concentraciones plasmáticas de tolvaptán y metabolito(s), incluidas las concentraciones plasmáticas de DM-4103.
    Criterios de valoración FD: OsmU y densidad específica de la orina
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy and Safety endpoints will be assessed throughout study up to
    and including the Follow up period (3 week post treatment end).
    PK endpoint assessed:
    End of the tolvaptan run-in period (Day -1)
    During the double-blind, randomized treatment period at Months 3, 6, 9,
    12/EoTx,
    At the last follow-up visit
    PD endpoint assessed:
    second visit of the screening period
    end of the placebo run-in period (Day -36)
    end of the tolvaptan titration period (Day -22)
    end of the tolvaptan run-in period (Day -1)
    during the double-blind, randomized treatment period at Months 3, 6, 9,
    and 12/EoTx
    at the last follow-up visit.
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Norway
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    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
    The end of trial date is defined as the last date of last contact with the subject.
    La fecha de final del ensayo se define como la fecha del último contacto con el sujeto
    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 months6
    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 months6
    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: 1270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 688
    F.4.2.2In the whole clinical trial 1300
    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)
    Patients who complete treatment will be offered entry into the 211
    Open Label Extension study. Patients who do not enter the 211 OLE
    will be treated as directed by their physician.
    los pacientes que completen el tratamiento completo se les ofrecerá entrar en el estudio de extensión 211.
    Los pacientes que no entren en el estudio 211 serán tratados directamente por sus médicos.
    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 Decision2015-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-14
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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