Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36835   clinical trials with a EudraCT protocol, of which   6081   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-019547-19
    Sponsor's Protocol Code Number:AMB112529
    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:2010-07-15
    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 number2010-019547-19
    A.3Full title of the trial
    Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años.
    A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.
    A.4.1Sponsor's protocol code numberAMB112529
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name VOLIBRIS 10 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO GROUP LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/05/273
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAMBRISENTAN
    D.3.9.3Other descriptive nameAMBRISENTAN
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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/3/05/273
    D.3 Description of the IMP
    D.3.1Product nameambrisentan
    D.3.2Product code GSK1325760
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNambrisentan
    D.3.9.2Current sponsor codeGSK1325760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name VOLIBRIS 5 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO GROUP LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/05/273
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAMBRISENTAN
    D.3.9.3Other descriptive nameAMBRISENTAN
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Hipertensión arterial pulmonar
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10064911
    E.1.2Term Hipertensión arterial pulmonar
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Hipertensión arterial pulmonar
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10065150
    E.1.2Term Hipertensión pulmonar arterial primaria asociada
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10065151
    E.1.2Term Hipertensión pulmonar arterial primaria idiopática
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10065152
    E.1.2Term Hipertensión pulmonar arterial primaria familiar
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es evaluar la seguridad y la tolerabilidad del ambrisentan en la población de niños (entre 8 y 18 años de edad) con HAP.
    E.2.2Secondary objectives of the trial
    Farmacocinética:
    • Evaluación de la farmacocinética poblacional a partir de una muestra de plasma por paciente en las semanas 4, 8, 12, 16, 20, y 24.
    • Desarrollo de un modelo farmacocinético/farmacodinámico.
    Eficacia
    • Variación con respecto al basal de la distancia recorrida en el Test de la Marcha de los 6 minutos (TM6M) después de 24 semanas de tratamiento.
    • Variación media con respecto al basal de la prueba de la TM6M en las semanas 4, 8, 12, 16 y 20.
    • Tiempo transcurrido hasta el empeoramiento clínico de la HAP.
    • Variación con respecto al basal de la evaluación global por el paciente realizada con el cuestionario de salud SF-10 para niños hasta la semana 24.
    • Variación con respecto al basal de la clase funcional de la OMS hasta la semana 24.
    • Variación con respecto al basal de la concentración plasmática del N-Terminal tipo pro-B péptido natriurético (NT-proBNP) en la semana 24.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-estudio de hemodinámica cardiopulmonar: Las evaluaciones hemodinámicas se efectuarán en el momento basal y en la semana 24 o en la retirada prematura en un subgrupo de pacientes reclutados en centros donde la recogida de datos hemodinámicos forma parte de la asistencia habitual.
    E.3Principal inclusion criteria
    1. Varón o mujer de 8 años de edad como mínimo y que no hayan cumplido los 18 años en el momento de la aleatorización.
    2. Diagnóstico actual de HAP (grupo 1 la OMS) con síntomas de clase II o III de la OMS de una de las siguientes categorías:
    • Idiopática
    • Heredable [familiar]
    • Secundaria a enfermedades del tejido conectivo (como esclerodermia limitada, esclerodermia difusa, enfermedad mixta del tejido conjuntivo, lupus eritematoso sistémico o síndrome de superposición).
    • HAP persistente a pesar de la reparación quirúrgica (al menos 6 meses antes de la visita de selección) de defectos del septo o tabique atrial, defectos del septo o tabique ventricular, defectos del septo o tabique atrio-ventricular y conducto arterial persistente.
    3. Cuando el cateterismo cardíaco derecho (CCD) se realice como parte del diagnóstico o la asistencia habituales, cumplir los criterios hemodinámicos siguientes (véase Apéndice 1):
    • presión arterial pulmonar media (PAPm) &#8805; 25 mmHg
    • resistencia vascular pulmonar (RVP) &#8805; 240 din. s/cm5
    • presión telediastólica del ventrículo izquierdo (PTDVI) o presión de enclavamiento capilar pulmonar (PECP) &#8804; 15 mmHg.
    4. Los sujetos podrán no haber recibido tratamiento previo (i.e. naïve), o deberán haber suspendido el tratamiento con otro ARE (por ejemplo, bosentan) al menos un mes antes debido a elevación de los parámetros de las pruebas de función hepática (PFH), o deberán haber recibido una dosis estable de medicación específica para la HAP (por ejemplo, sildenafilo o prostaciclina) durante al menos un mes antes de la visita de selección. El tratamiento de base de la medicación específica para la HAP, en su caso, no debe modificarse desde la visita de selección hasta el final de todas las evaluaciones del periodo de tratamiento.
    5. En los sujetos en los que se haya suspendido el tratamiento con un ARE debido a la elevación en las PFH, los resultados de las PFH deberán ser < 3 veces el límite superior de la normalidad (LSN).
    6. Una mujer podrá para participar en este estudio, tras la evaluación por el investigador, en caso de que:
    a. no sea potencialmente fértil (es decir, que sea fisiológicamente incapaz de concebir) ; o,
    b. si es potencialmente fértil, tenga un resultado negativo en la prueba de embarazo y no se encuentre en período de lactancia en las visitas de selección y basal/ de aleatorización y si es sexualmente activa y se comprometa a utilizar dos métodos anticonceptivos fiables desde la visita de selección hasta la finalización del estudio y durante al menos 30 días después de la última dosis del fármaco del estudio (los métodos anticonceptivos fiables se enumeran en el Apéndice 2).
    7. El sujeto o su tutor legal es capaz y está dispuesto a dar su consentimiento informado por escrito. Como parte del consentimiento, las mujeres potencialmente fértiles serán informadas del riesgo de teratogenia y deberán recibir información, adecuada a su grado de madurez, acerca de la importancia evitar el embarazo; los varones deberán ser informados del riesgo de sufrir atrofia de los túbulos testiculares y aspermia.
    E.4Principal exclusion criteria
    1. Sujetos en tratamiento con un ARE.
    2. Sujetos en tratamiento con ciclosporina A.
    3. Sujetos con un peso corporal inferior a 20 kg.
    4. Sujetos que no toleraron el tratamiento para la HAP debido a efectos adversos posiblemente relacionados con su mecanismo de acción (como prostanoides, ARE, inhibidores de la PDE-5), con la excepción de las anomalías hepáticas en los sujetos que recibían otro ARE.
    5. Mujeres embarazadas o en período de lactancia.
    6. Sujetos con un diagnóstico de hepatitis activa (anticuerpos contra el antígeno de superficie del virus de la hepatitis B y anticuerpos contra el virus de la hepatitis C) o una elevación clínicamente importante de las enzimas hepáticas (ALT, AST o FA > 3 veces el LSN) en la visita de selección.
    7. Sujetos con insuficiencia renal grave (aclaramiento de creatinina < 30 ml/min) en la visita de selección.
    8. Sujetos con una retención de líquidos clínicamente importante en opinión del investigador.
    9. Sujetos con anemia clínicamente importante en opinión del investigador.
    10. Sujetos con hipersensibilidad conocida al fármaco del estudio, sus metabolitos o a los excipientes de la formulación.
    11. Sujetos que hayan participado en otro ensayo o hayan recibido otro producto en investigación en los 30 días anteriores.
    12. Alcoholismo, consumo de drogas en el año anterior.
    13. Cualquier enfermedad concurrente o uso concomitante de medicación que, en opinión del investigador, pueda afectar a la seguridad del sujeto.
    E.5 End points
    E.5.1Primary end point(s)
    Seguridad:
    • Acontecimientos adversos
    • Acontecimientos adversos graves
    • Parámetros de laboratorio clínico
    • Exploración física (talla, peso, índice de masa corporal/ superficie corporal, saturación de oxígeno, presión venosa yugular, tamaño hepático y presencia de edema periférico o ascitis)
    • Constantes vitales
    • Desarrollo puberal (variación de los resultados de la evaluación endocrinológica de las semanas 12 y 24 con respecto al basal).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diferentes dosis del mismo MI
    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 concerned3
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    No aplicable
    Nota: Los pacientes que participen en el estudio y en los que es adecuado continuar tratamiento con ambrisentan serán elegibles para participar en un estudio de seguimiento a largo plazo.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-07-15. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Los padres o tutores legales darán consentimiento (niños de 8 a 11). Particpante y padres/tutores Darán Consentimiento (12 a 17). Los de 18 darán consentimiento ellos mismos.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 66
    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)
    Los pacientes que participen en el estudio y en los que es adecuado continuar tratamiento con ambrisentan serán elegibles para participar en un estudio de seguimiento a largo plazo.
    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 Decision2010-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-11
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA