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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-004958-18
    Sponsor's Protocol Code Number:20130356
    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:2014-06-27
    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 number2013-004958-18
    A.3Full title of the trial
    A Randomized, Open-label, Controlled Study to Assess the Efficacy and
    Safety of Cinacalcet HCl in Pediatric Subjects With Secondary
    Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
    Estudio aleatorizado, abierto y controlado para evaluar la eficacia y seguridad de cinacalcet HCl en sujetos pediátricos con hiperparatiroidismo secundario e insuficiencia renal crónica sometidos a diálisis
    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 Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
    Estudio para evaluar la eficacia y seguridad de cinacalcet HCl en sujetos pediátricos con hiperparatiroidismo secundario e insuficiencia renal crónica sometidos a diálisis
    A.4.1Sponsor's protocol code number20130356
    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 SponsorAmgen, 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 supportAmgen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number900850153
    B.5.6E-mailMedinfoInternational@amgen.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 namecincacalet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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 INNCinacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    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 nameCinacalcet Hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Suspension and effervescent granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNCincacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 namecinacalcet
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNCinacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
    Hiperparatiroidismo secundario (HPTS) Insuficiencia renal crónica (IRC) sometidos a diálisis.
    E.1.1.1Medical condition in easily understood language
    Secondary Hyperparathyroidism and Chronic Kidney Disease
    Hiperparatiroidismo secundario e Insuficiencia renal crónica.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10020708
    E.1.2Term Hyperparathyroidism secondary
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%
    Evaluar la eficacia de cinacalcet para reducir el nivel plasmático de hormona paratiroidea intacta (PTHi) en ≥ 30%.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of cinacalcet for lowering the plasma iPTH level to ≤ 300 pg/mL (31.8 pmol/L)
    • To evaluate the impact of cinacalcet on corrected total serum calcium level
    • To evaluate the impact of cinacalcet on serum phosphorus level
    - Evaluar la eficacia de cinacalcet para reducir el nivel plasmático de PTHi a ≤ 300 pg/mL (31,8 pmol/L).
    - Evaluar el impacto de cinacalcet en el nivel de calcio sérico total corregido.
    - Evaluar el impacto de cinacalcet en el nivel de fósforo sérico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
    - Age 6 to < 18 years old at time of randomization
    - Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis for ≥ 30 days prior to screening
    - Dry weight ≥ 25.0 kg during screening
    - Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
    - Corrected calcium value ≥ 8.8 mg/dL obtained from the central laboratory during screening
    - Dialysate calcium level ≥ 2.5 mEq/L during screening
    - El representante legal autorizado del sujeto ha dado su consentimiento informado cuando el sujeto es legalmente demasiado joven para dar su consentimiento informado y el sujeto ha dado su asentimiento por escrito de acuerdo con las normativas y/o directrices locales antes de iniciar cualquier actividad/procedimiento específico del estudio.
    - Edad de 6 a < 18 años en el momento de la aleatorización.
    - Diagnóstico de IRC, con hemodiálisis o diálisis peritoneal, durante ≥ 30 días antes de la selección.
    - Peso seco ≥ 25,0 kg durante la selección.
    - Diagnóstico de HPTS con la media de 2 valores de PTHi consecutivos del laboratorio central ≥ 300 pg/mL durante la selección.
    - Valor de calcio corregido ≥ 8,8 mg/dL obtenido del laboratorio central durante la selección.
    Nivel de calcio en el dializado ≥ 2,5 mEq/L durante la selección.
    E.4Principal exclusion criteria
    - Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
    - Other investigational procedures while participating in this study are excluded 203 Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
    - Subject has known sensitivity to any of the products to be administered during dosing
    - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary) to the best of the subject and investigator’s knowledge
    - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
    - Subject previously has entered this study
    - If sexually active, subject is not willing to use highly effective contraception during treatment and for at least 9 days after the end of treatment
    - Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
    - History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias or other conditions associated with prolonged QT interval
    - Receipt of cinacalcet (within 30 days of screening)
    During screening:
    - Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula
    - QTc ≥ 450 to ≤ 500 ms, using Bazett’s formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
    - Use of grapefruit juice, herbal medications or potent CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
    -Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol)
    - Receipt of cinacalcet
    At time of randomization, scheduled for or expect:
    - Renal transplant within 90 days
    -Estar recibiendo actualmente tratamiento en otro estudio de un fármaco o dispositivo en investigación o haber transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de un fármaco o dispositivo en investigación.
    -Quedan excluidos otros procedimientos experimentales durante la participación en este estudio.
    -Tumor maligno, excepto cáncer de piel no melanomatoso y carcinoma cervical o ductal de mama in situ, en los últimos 5 años.
    -El sujeto presenta una sensibilidad conocida a alguno de los productos que se administrarán durante la dosificación.
    -Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos del estudio (p. ej., diario electrónico del paciente).
    -Antecedentes o evidencia de cualquier otro trastorno, condición o enfermedad clínicamente significativo (excepto los indicados anteriormente) que, en opinión del investigador o del médico de Amgen, si se le consulta, pudieran suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la realización del estudio.
    -El sujeto ya ha sido incluido anteriormente en este estudio.
    -Si el sujeto es sexualmente activo y no está dispuesto a utilizar métodos anticonceptivos altamente eficaces durante el tratamiento y durante al menos 9 días después de finalizar el tratamiento.
    -Mujer embarazada o en período de lactancia, o que planee quedarse embarazada durante el estudio o en los 9 días posteriores al fin del tratamiento.
    -Antecedentes de síndrome de QT largo congénito, bloqueo cardíaco de segundo o tercer grado, taquiarritmias ventriculares u otras enfermedades asociadas a un intervalo QT prolongado.
    -En los 30 días anteriores a la selección
    Recepción de cinacalcet.
    -Durante la selección
    Intervalo QT corregido (QTc) > 500 ms, utilizando la fórmula de Bazett.
    QTc de ≥ 450 a ≤ 500 ms, utilizando la fórmula de Bazett, a no ser que el investigador dé su permiso por escrito para la inclusión tras consultar con un cardiólogo pediátrico.
    Uso de zumo de pomelo, fitomedicamentos o inhibidores potentes de CYP3A4 (p. ej., eritromicina, claritromicina, ketoconazol e itraconazol).
    Uso de medicaciones concomitantes que pueden prolongar el intervalo QT corregido (p. ej., ondansetrón y albuterol).
    Recepción de cinacalcet.
    -En el momento de la aleatorización, programada o prevista
    Trasplante renal en los 90 días posteriores.
    E.5 End points
    E.5.1Primary end point(s)
    Achievement of a ≥ 30% reduction from baseline in mean plasma iPTH during the efficacy assessment period (EAP), defined as Week 17 – 20.
    Consecución de una reducción ≥ 30% desde el nivel basal en la PTHi plasmática media durante el período de evaluación de la eficacia (PEE), definido como el período comprendido entre las semanas 17 y 20.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 17 – 20
    Semanas 17-20
    E.5.2Secondary end point(s)
    • Achievement of a mean iPTH ≤ 300 pg/mL (31.8 pmol/L) during the EAP
    • Percent change in iPTH from baseline to the mean value during the EAP
    • Change in corrected total serum calcium from baseline to the mean value during the EAP
    • Change in serum phosphorus from baseline to the mean value during the EAP
    -Consecución de una PTHi media ≤ 300 pg/mL (31,8 pmol/L) durante el PEE.
    -Cambio porcentual en la PTHi desde el nivel basal hasta el valor medio durante el PEE.
    -Cambio en el calcio sérico total corregido desde el nivel basal hasta el valor medio durante el PEE.
    -Cambio en el fósforo sérico desde el nivel basal hasta el valor medio durante el PEE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 17 – 20
    Semanas 17-20
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento Estandar
    Standard of care
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Austria
    Belgium
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Lithuania
    Luxembourg
    Mexico
    Netherlands
    Poland
    Portugal
    Russian Federation
    Slovakia
    South Africa
    Spain
    Switzerland
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    When the last subject is assessed or receives an intervention for the purposes of final collection of data
    El fin del estudio es la fecha de finalización principal. Se define como el momento en que el último sujeto se evalúa o recibe una intervención con la intención de recopilar los últimos datos para el análisis principal.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 48
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    F.1.2Adults (18-64 years) No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 48
    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)
    There will be a four week safety follow up period, following end of treatment.
    Habrá 4 semanas de seguimiento de seguridad a la finalización del tratamiento.
    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 Decision2014-09-24
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-23
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