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    Summary
    EudraCT Number:2016-000826-21
    Sponsor's Protocol Code Number:AC-078A201
    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:2016-10-04
    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 number2016-000826-21
    A.3Full title of the trial
    Multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group, polysomnography dose response study to assess the efficacy and safety of ACT-541468 in adult subjects with insomnia disorder
    Estudio multicéntrico, doble ciego, aleatorizado, controlado con placebo, de referencia activa, con grupos paralelos y polisomnográfico de respuesta a una dosis dada para evaluar la eficacia y la seguridad de ACT-541468 en sujetos adultos con insomnio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of ACT-541468 in adult subjects suffering from difficulties to sleep
    Estudio para evaluar la eficacia y seguridad de ACT-541468 en sujetos adultos que sufren dificultades para dormir.
    A.4.1Sponsor's protocol code numberAC-078A201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02839200
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 supportActelion Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinical-trials-disclosure@actelion.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 name-
    D.3.2Product code ACT-541468
    D.3.4Pharmaceutical form Capsule, hard
    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 INN-
    D.3.9.2Current sponsor codeACT-541468
    D.3.9.4EV Substance CodeSUB169826
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 name-
    D.3.2Product code ACT-541468
    D.3.4Pharmaceutical form Capsule, hard
    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 INN-
    D.3.9.2Current sponsor codeACT-541468
    D.3.9.4EV Substance CodeSUB169826
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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 name-
    D.3.2Product code ACT-541468
    D.3.4Pharmaceutical form Capsule, hard
    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 INN-
    D.3.9.2Current sponsor codeACT-541468
    D.3.9.4EV Substance CodeSUB169826
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 4
    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 Stilnox®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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 INNZolpidem Tartrate
    D.3.9.1CAS number 99294-93-6
    D.3.9.4EV Substance CodeSUB05192MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule, hard
    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 placeboCapsule, hard
    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
    Insomnia disorder
    Trastorno de insomnio
    E.1.1.1Medical condition in easily understood language
    Difficulty to sleep
    Dificultad para dormir
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10022437
    E.1.2Term Insomnia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 the study is to evaluate the dose-response of ACT-541468 on the change of WASO [Wake After Sleep Onset] assessed by Polysomnography [PSG] after treatment on Days 1 and 2
    El objetivo principal del estudio es evaluar la respuesta a una dosis de ACT-541468 sobre el cambio del despertar después del inicio del sueño (WASO; minutos) determinada mediante polisomnografía (PSG) después del tratamiento los días 1 y 2.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the dose response of ACT-541468 on Latency to Persistent Sleep (LPS) on Days 1&2 and Subjective Latency to Sleep Onset (sLSO) and subjective Wake After Sleep Onset (sWASO) at Week 4
    El objetivo secundario del estudio consiste en evaluar la respuesta a una dosis de ACT-541468 sobre la latencia para el sueño continuado (LPS) los días 1 y 2 y la latencia subjetiva después del inicio del sueño (sLSO) y el WASO subjetivo (sWASO) en la semana 4.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent prior to any study-mandated procedure
    - Male or female aged 18-64 years (inclusive)
    - Women of childbearing potential must have a negative and urine pregnancy test and use reliable methods of contraception up to 30 days after EOT
    - Body mass index (BMI): 18.5 <= BMI (kg/m2) < 32.0
    - Insomnia disorder according to DSM-5 criteria
    - Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
    - Insomnia Severity Index score >= 15.
    - Firma del consentimiento informado antes de realizar cualquier procedimiento del estudio.
    - Varón o mujer de 18 a 64 años (ambos inclusive).
    - Las mujeres fértiles deben aportar una prueba de embarazo en sangre y orina negativa y un compromiso de someterse a pruebas de embarazo hasta 30 días después del FdT.
    - Índice de masa corporal (IMC): 18,5 <= IMC (kg/m2) < 32,0.
    - Insomnio con arreglo a los criterios del DSM-5.
    - Cantidad de sueño insuficiente como subjetivamente recogido en el diario de sueño y validado objetivamente mediante polisomnografía.
    - Puntuación en el Índice de gravedad del insomnio (isi©) >= 15
    E.4Principal exclusion criteria
    - Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
    - Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
    - Caffeine consumption >= 600 mg per day.
    - Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
    - Travel >= 3 time zones within 1 week prior to the screening visit, or planned travel >= 3 time zones during study.
    - Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
    - AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN - Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
    - History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
    - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
    - Cualquier trastorno del sueño distinto de insomnio, o antecedentes de trastorno respiratorio relacionado, trastorno de movimientos periódicos de las extremidades, síndrome de piernas inquietas, trastorno del ritmo circadiano, trastorno de conducta del sueño REM o narcolepsia.
    - Siesta habitual por el día autorreferida >= 1 hora al día y >= 3 días a la semana.
    - Consumo de cafeína >= 600 mg al día.
    - Trabajo por turnos en las 2 semanas anteriores a la visita de selección, o trabajo por turnos planificado durante el estudio.
    - Viajes a >= 3 zonas horarias dentro de la semana anterior a la visita de selección o viajes planificados a >= 3 zonas horarias durante el estudio.
    -Resultados de pruebas de hematología y bioquímica sanguínea que se desvían del intervalo normal de forma clínicamente importante según criterio del investigador.
    - Aspartato aminotransferasa y/o alanina aminotransferasa > 2 x el límite superior de la normalidad (LSN) y/o bilirrubina directa > 1.5 x LSN - Insuficiencia renal grave (salvo antecedentes documentados de síndrome de Gilbert).
    - Estado médico inestable, trastorno médico significativo o enfermedad aguda dentro del mes anterior a la visita de selección, que en opinión del investigador podría afectar a la seguridad del sujeto o interferir con las evaluaciones del estudio.
    - Cualquier circunstancia o situación que, en opinión del investigador, pueda afectar a la plena participación del sujeto en el estudio o el cumplimiento del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Change of WASO ( Wake after Sleep Onset) from baseline to Days 1 & 2 as determined by
    Polysomnography (PSG).
    Variación de WASO (min) desde el inicio hasta los días 1 y 2 según lo determinado por polisomnografía (PSG).
    El WASO (min) es el tiempo que se ha permanecido despierto después del inicio del sueño persistente hasta que se encienden las luces determinado mediante PSG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Days 1&2
    Desde el inicio hasta los Días 1 y 2.
    E.5.2Secondary end point(s)
    1- Sleep initiation endpoints including:
    Change from baseline to Days 1 & 2 in mean LPS (Latency to Persistent Sleep);
    Change from baseline to Week 4 in mean sLSO (self reported Latency to Sleep Onset)
    2- Sleep maintenance endpoint:
    Change from baseline to Week 4 in mean sWASO [self-reported Subjective Wake after Sleep Onset]
    1- Criterios de valoración de inicio del sueño:
    Variación desde el inicioa hasta los días 1 y 2 en el LPS medio.
    El LPS (min) es el tiempo desde el inicio del registro hasta el principio de las 20 primeras epochs continuas (es decir, 10 minutos) calificadas como no-despierto, es decir, epoch calificadas como fase 1 del sueño (S1), fase 2 del sueño (S2), fase 3 del sueño (sueño REM), determinado mediante PSG.
    Variación desde el inicioc hasta la semana 4 en el sLSO subjetivo medio.
    El sLSO es el tiempo que el sujeto afirma que tarda en quedarse dormido, según lo indicado en el diario de sueño.
    2- Criterios de valoración de mantenimiento del sueño:
    Variación desde el inicioc hasta la semana 4 en el sWASO subjetivo medio.
    El sWASO es el tiempo que el sujeto afirma que ha permanecido dormido después del inicio del sueño, según lo indicado en el diario de sueño.
    E.5.2.1Timepoint(s) of evaluation of this end point
    LPS: From Baseline to Days 1&2 ;
    sLSO: From Baseline to Week 4;
    sWASO: From Baseline to Week 4.
    LPS: desde el inicio hasta los Días 1 y 2;
    sLSO: desde el inicio hasta hasta la semana 4;
    sWASO: desde el inicio hasta hasta la semana 4.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Germany
    Hungary
    Israel
    Spain
    Sweden
    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
    Last Visit Last Subject
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 300
    F.1.3Elderly (>=65 years) No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 300
    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)
    After the subject’s study completion or premature withdrawal from the study, whichever applies, the
    investigator will explain to subjects what treatment(s) / medical care is necessary and available according
    to local regulations
    Después de que el sujeto finalice el estudio o la retirada prematura del estudio, según corresponda, el investigador le explicará a los sujetos que tratamiento (s) / atención médica es necesaria y disponible de acuerdo a las regulaciones locales.
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-20
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    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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