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    Summary
    EudraCT Number:2013-005118-36
    Sponsor's Protocol Code Number:NOH401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-05-22
    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 number2013-005118-36
    A.3Full title of the trial
    A clinical study of Patients with symptomatic neurogenic orthostatic HypOtENsion to assess sustaIned effects of droXidopa therapy
    Estudio clínico en pacientes con hipotensión ortostática neurógena sintomática para evaluar los efectos mantenidos del tratamiento con droxidopa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the long-term effects of droxidopa treatment in patients who experience low blood pressure when changing their posture
    Un estudio para examinar los efectos a largo plazo del tratamiento droxidopa en pacientes que sufren de presión arterial baja al cambiar su postura
    A.3.2Name or abbreviated title of the trial where available
    PHOENIX
    PHOENIX
    A.4.1Sponsor's protocol code numberNOH401
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01927055
    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 SponsorChelsea Therapeutics, Incorporated
    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 supportChelsea Therapeutics, Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Plc
    B.5.2Functional name of contact pointSenior Project Manager
    B.5.3 Address:
    B.5.3.1Street Address79 T.W. Alexander Drive , Research Commons Building
    B.5.3.2Town/ cityDurham
    B.5.3.3Post codeNC-27709-4353
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034932275785
    B.5.5Fax number1267519-1248
    B.5.6E-mailJoyce.Whiteside@iconplc.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/31/07/465; EU/31/07/466
    D.3 Description of the IMP
    D.3.1Product nameDroxidopa
    D.3.2Product code Droxidopa
    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 INNDROXIDOPA
    D.3.9.1CAS number 23651-95-8
    D.3.9.2Current sponsor codeDROXIDOPA
    D.3.9.3Other descriptive name(-)-threo-3-(3,4-dihydroxyphenyl)-L-serine
    D.3.9.4EV Substance CodeSUB06420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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/31/07/465; EU/31/07/466
    D.3 Description of the IMP
    D.3.1Product nameDroxidopa
    D.3.2Product code Droxidopa
    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 INNDROXIDOPA
    D.3.9.1CAS number 23651-95-8
    D.3.9.2Current sponsor codeDROXIDOPA
    D.3.9.3Other descriptive name(-)-threo-3-(3,4-dihydroxyphenyl)-L-serine
    D.3.9.4EV Substance CodeSUB06420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.2.5.1Orphan drug designation numberEU/31/07/465; EU/31/07/466
    D.3 Description of the IMP
    D.3.1Product nameDroxidopa
    D.3.2Product code Droxidopa
    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 INNDROXIDOPA
    D.3.9.1CAS number 23651-95-8
    D.3.9.2Current sponsor codeDROXIDOPA
    D.3.9.3Other descriptive name(-)-threo-3-(3,4-dihydroxyphenyl)-L-serine
    D.3.9.4EV Substance CodeSUB06420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 3
    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
    Symptomatic neurogenic orthostatic hypotension
    Hipotensión ortostática neurógena sintomática
    E.1.1.1Medical condition in easily understood language
    Patients that experience symptoms of low blood pressure when changing their posture
    Los pacientes que experimentan síntomas de presión arterial baja al cambiar su postura
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10031127
    E.1.2Term Orthostatic hypotension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the clinical efficacy of droxidopa versus placebo, as demonstrated by improvements in dizziness (OHSA Item #1) from randomization over a 12 week (maximum) treatment period in patients with symptomatic neurogenic orthostatic hypotension
    Evaluar la eficacia clínica de la droxidopa en comparación con placebo a través de la mejoría del mareo (elemento n.º 1 de la escala de Evaluación de síntomas de la hipotensión ortostática [OHSA]) desde la aleatorización a lo largo de un periodo de tratamiento de 12 semanas (máximo) en pacientes con HOn sintomática.
    E.2.2Secondary objectives of the trial
    Evaluate the clinical efficacy of droxidopa versus placebo using endpoints derived from the OHQ, Clinical Global Impression-Improvement (CGI-I), Clinical Global Impression-Severity (CGI-S) and Boston University Activity Measure For Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form questionnaires, as well as assessment of patient-reported falls, and BP measurements during the orthostatic standing tests.
    Evaluar la eficacia clínica de la droxidopa en comparación con placebo mediante el uso de criterios de valoración derivados del Cuestionario de hipotensión ortostática (OHQ), la Escala de impresión clínica global ? Mejoría (CGI-I), la Escala de impresión clínica global ? Gravedad (CGI-S) y el Cuestionario abreviado de movilidad básica para pacientes ambulantes de la Escala de actividad para cuidados posagudos (AM-PAC) de la Universidad de Boston, así como la evaluación de las caídas comunicadas por los pacientes y las mediciones de la presión arterial (PA) durante las pruebas ortostáticas en pie. La seguridad de la droxidopa en comparación con placebo se evaluará mediante los acontecimientos adversos (AA), los exámenes de las constantes vitales, los ECG y las pruebas analíticas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years or older and ambulatory (defined as able to walk at least 10 meters)
    2. Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA, and PAF) or Dopamine Beta Hydroxylase Deficiency
    3. At the Baseline visit (Visit 2), patients must demonstrate:
    a. a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item #1
    b. a fall of at least 20 mmHg in their SBP, within 3 minutes of standing
    4. Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
    1. Personas de 18 años o más ambulantes (definido como personas capaces de caminar al menos 10 metros)
    2. Diagnóstico clínico de hipotensión ortostática sintomática asociada a insuficiencia autonómica primaria (EP, AMS e IAP) o con deficiencia de dopamina ?-hidroxilasa
    3. En la visita inicial (visita 2), los pacientes deben presentar:
    a. Una puntuación de al menos 4 o más en el elemento n.º 1 de la Evaluación de síntomas de hipotensión ortostática (OHSA)
    b. Un descenso de al menos 20 mmHg en la PAS en los 3 minutos siguientes a ponerse de pie
    4. Otorgar consentimiento informado por escrito para participar en el estudio entendiendo que pueden retirar su consentimiento en cualquier momento sin perjuicio de su atención médica futura
    E.4Principal exclusion criteria
    1. Score of 23 or lower on the mini-mental state examination (MMSE)
    2. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;
    a. Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study
    3. Known or suspected alcohol or substance abuse within the past 12 months
    4. Women who are pregnant or breastfeeding
    5. Women of childbearing potential (WOCP) who are not using at least one method of contraception with their partner
    6. Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic, or have these measurements at their Baseline Visit (Visit 2). Sustained is defined as measurements persistently greater at 2 separate measurements at least 10 minutes apart with the subject supine and at rest for at least 5 minutes
    7. Untreated closed angle glaucoma
    8. Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine hypertension are allowed in this study)
    9. Any significant uncontrolled cardiac arrhythmia
    10. History of myocardial infarction, within the past 2 years
    11. Current unstable angina
    12. Congestive heart failure (NYHA Class 3 or 4)
    13. Diabetic autonomic neuropathy
    14. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ
    15. Gastrointestinal condition that may affect the absorption of study drug (e.g., ulcerative colitis, gastric bypass)
    16. Any major surgical procedure within 30 days prior to the Baseline visit (Visit 2)
    17. Previously treated with droxidopa within 30 days prior to the Baseline visit (Visit 2)
    18. Currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the Baseline visit (Visit 2)
    19. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study
    20. The Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures
    1. Puntuación de 23 o menos en el Miniexamen cognoscitivo (MMSE)
    2. Uso concomitante de vasoconstrictores para elevar la presión arterial
    a. Los pacientes que tomen vasoconstrictores como efedrina, dihidroergotamina o midodrina deben dejar de tomar estos fármacos al menos 2 días o 5 semividas (lo que sea más largo) antes de su visita inicial (visita 2) y a lo largo de todo el estudio
    3. Abuso del alcohol o de sustancias conocidos o de sospecha en los 12 meses anteriores (definición de abuso del alcohol o de sustancias del Manual diagnóstico y estadístico de los trastornos mentales, versión IV [DSM-IV])
    4. Mujeres embarazadas o en período de lactancia
    5. Mujeres con capacidad reproductiva (MCR) que no utilicen al menos un método anticonceptivo con su pareja
    6. Hipertensión mantenida en decúbito supino mayor o igual a 180 mmHg de presión sistólica o 110 mmHg de presión diastólica, o presentar estos valores en su visita inicial (visita 2). El término mantenida se define como valores persistentemente superiores en 2 mediciones separadas al menos 10 minutos entre sí, con el paciente en decúbito supino y en reposo durante al menos 5 minutos
    7. Glaucoma de ángulo cerrado sin tratar
    8. Diagnóstico de hipertensión que requiera tratamiento con antihipertensivos (en este estudio se permiten los antihipertensivos de acción rápida para tratar la hipertensión nocturna en decúbito supino)
    9. Cualquier arritmia cardíaca incontrolada significativa
    10. Antecedentes de infarto de miocardio en los 2 años anteriores
    11. Angina inestable en curso
    12. Insuficiencia cardíaca congestiva (clases 3 o 4 según la Asociación Neoyorquina del Corazón [NYHA])
    13. Neuropatía autonómica diabética
    14. Antecedentes de cáncer en los 2 años previos, salvo carcinoma espinocelular de piel, carcinoma basocelular o carcinoma cervicouterino in situ, no metastásicos y tratados con éxito
    15. Trastorno digestivo que pueda afectar a la absorción del fármaco de estudio (p. ej., colitis ulcerosa o derivación gástrica)
    16. Intervención de cirugía mayor en los 30 días previos a la visita inicial (visita 2)
    17. Tratamiento con droxidopa en los 30 días previos a la visita inicial (visita 2)
    18. Tratamiento con cualquier otro fármaco experimental en curso o en los 30 días previos a la visita inicial (visita 2)
    19. Cualquier afección o resultado analítico que, a juicio del investigador, pueda incrementar el riesgo para el paciente o afectar a su participación en el estudio
    20. El investigador tiene la capacidad de excluir a un paciente si por algún motivo considera que este no es un buen candidato para el estudio o no va a ser capaz de seguir los procedimientos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Relative mean change in OHSA Item #1 from Randomization (Visit 4) to Week 1 (Visit 5).
    Cambio medio relativo en el elemento n.º 1 de la OHSA desde la aleatorización (visita 4) hasta la semana 1 (visita 5).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits 4 and 5
    Visita 4 y 5
    E.5.2Secondary end point(s)
    1. Relative mean change in OHSA Item #1 from Randomization (Visit 4) to Week 12 (Visit 8)
    2. Patient reported falls from Randomization (Visit 4) to Week 12 (Visit 8)
    3. Change in standing blood pressure (systolic and diastolic) from Randomization (Visit 4) to Week 12 (Visit 8)
    4. Relative mean change in the OHQ Composite score and individual item scores from Randomization (Visit 4) to Week 12 (Visit 8)
    5. Relative mean change in the Global assessment evaluations using the clinician-recorded and patient-recorded CGI-S scales from Randomization (Visit 4) to Week 12 (Visit 8)
    6. Relative mean change in the Global assessment of improvement of disease status using the clinician recorded and patient-recorded CGI-I scales from Week 1 (Visit 5) to Week 12 (Visit 8)
    7. Relative mean change in the AM-PAC Basic Mobility Outpatient Short Form score from Randomization (Visit 4) to Week 12 (Visit 8)
    1. Cambio medio relativo en el elemento n.º 1 de la OHSA desde la aleatorización (visita 4) hasta la semana 12 (visita 8)
    2. Caídas comunicadas por el paciente desde la aleatorización (visita 4) hasta la semana 12 (visita 8)
    3. Cambio en la presión arterial en pie (sistólica y diastólica) desde la aleatorización (visita 4) hasta la semana 12 (visita 8)
    4. Cambio medio relativo en la puntuación combinada del OHQ y en las puntuaciones de los elementos individuales desde la aleatorización (visita 4) hasta la semana 12 (visita 8)
    5. Cambio medio relativo en las evaluaciones globales obtenidas mediante las escalas CGI-S rellenadas por el médico y por el paciente desde la aleatorización (visita 4) hasta la semana 12 (visita 8)
    6. Cambio medio relativo en las evaluaciones globales de mejoría del estado de la enfermedad obtenidas mediante las escalas CGI-I rellenadas por el médico y por el paciente desde la semana 1 (visita 5) hasta la semana 12 (visita 8)
    7. Cambio medio relativo en la puntuación del Cuestionario abreviado de movilidad básica para pacientes ambulantes AM-PAC desde la aleatorización (visita 4) hasta la semana 12 (visita 8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Relative mean change in OHSA Item #1 from Randomization to Week 12 - Visits 6, 7 and 8
    2. Patient reported falls - Visits 6, 7 and 8
    3. Change in standing blood pressure - Visits 6, 7 and 8
    4. Relative mean change in the OHQ Composite score and individual item scores - Visits 6, 7 and 8
    5. Relative mean change in the Global assessment evaluations - Visits 6, 7 and 8
    6. Relative mean change in the Global assessment of improvement of disease status - Visits 6, 7 and 8
    7. Relative mean change in the AM-PAC Basic Mobility Outpatient Short Form score - Visits 6, 7 and 8
    1. Cambio promedio relativo en OHSA Artículo # 1 desde la aleatorización hasta la semana 12 - Visitas 6, 7 y 8
    2. Paciente informó caídas - Visitas 6, 7 y 8
    3. Cambio en la presión arterial de pie - Visitas 6, 7 y 8
    4. Cambio promedio relativo en el puntaje compuesto y elemento individual puntajes OHQ - Visitas 6, 7 y 8
    5. Cambio promedio relativo en las evaluaciones globales de evaluación - Visitas 6, 7 y 8
    6. Cambio promedio relativo en la evaluación global de la mejora de la condición de la enfermedad - Visitas 6, 7 y 8
    7. El cambio medio en la puntuación relativa AM-PAC básico Movilidad Ambulatorio Short Form - Visitas 6, 7 y 8
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 EEA41
    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
    France
    Germany
    Italy
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 450
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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