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    The EU Clinical Trials Register currently displays   43845   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:2009-011150-17
    Sponsor's Protocol Code Number:AMB112565
    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:2010-06-02
    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 number2009-011150-17
    A.3Full title of the trial
    AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primaria
    AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension
    A.3.2Name or abbreviated title of the trial where available
    AMBITION
    A.4.1Sponsor's protocol code numberAMB112565
    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 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 typeup to
    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.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 Yes
    D.2.1.1.1Trade name CIALIS 20 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    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 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 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 INNTADALAFILO
    D.3.9.3Other descriptive nameTADALAFIL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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
    Hipertensión arterial pulmonar
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    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 11
    E.1.2Level LLT
    E.1.2Classification code 10064911
    E.1.2Term Hipertensión arterial pulmonar
    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 comparar las dos estrategias de tratamiento: el tratamiento combinado de primera línea (ambrisentán y tadalafilo) y la monoterapia de primera línea (ambrisentán o tadalafilo), en sujetos con HAP. Se valorará mediante el tiempo hasta el primer episodio de fracaso clínico.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio son comparar el cambio de otras medidas clínicas de la HAP tras el inicio de tratamiento combinado o monoterapia de primera línea en sujetos con HAP.
    Se compararán la seguridad y la tolerabilidad del tratamiento combinado y la monoterapia, administrados ambos como primera línea.
    Se valorará además el efecto del ambrisentán, en concentraciones plasmáticas pico y valle, sobre la capacidad de ejercicio de los sujetos con hipertensión arterial pulmonar (HAP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. El sujeto deberá tener entre 18 y 75 años de edad, ambos inclusive, en la visita de selección
    2. El sujeto deberá pesar &#61619;40 kg en la visita de selección
    3. Los sujetos deberán tener un diagnóstico de HAP debida a:
    a. HAP idiopática o hereditaria
    b. HAP asociada con:
    i. enfermedad del tejido conjuntivo (p. ej., esclerodermia limitada o difusa, ETC mixta, lupus eritematoso diseminado o síndrome de solapamiento)
    ii. fármacos o toxinas
    iii. infección por el VIH
    iv. defectos cardíacos congénitos reparados más de un año antes de la selección (es decir, defectos del tabique auricular o ventricular y conducto arterioso permeable)
    Nota: los sujetos con hipertensión portopulmonar y EVOP NO son elegibles para el estudio
    4. El sujeto deberá tener un diagnóstico actual de estar en una clase funcional II o III de la OMS.
    5. Los sujetos con diagnóstico de VIH deberán tener enfermedad estable. En este estudio, el estado estable del VIH se define como:
    i. Ausencia de adición de medicamentos para tratar el VIH en al menos las 8 semanas previas a la selección
    ii. Ausencia de infecciones oportunistas durante el período de selección
    iii. Ausencia de hospitalizaciones debidas al VIH en al menos las 4 semanas previas a la selección
    6. El sujeto deberá cumplir todos los criterios hemodinámicos siguientes en un cateterismo del corazón derecho antes de la selección:
    iv. PAPm &#61619;25 mm Hg
    v. RVP &#61619;240 dinas&#61655;seg/cm5
    vi. PCPE o PTDVI &#8804;15 mm Hg
    E.4Principal exclusion criteria
    1. El sujeto ha recibido tratamiento previo para la HAP (IPDE5, ARE, prostanoide crónico*) en las 4 semanas previas a la visita de selección
    *Se considera uso crónico de prostanoides el tratamiento durante >7 días
    2. El sujeto ha recibido tratamiento con ARE (p. ej., bosentán o sitaxentán) o IPDE5 (p. ej., sildenafilo) en cualquier momento Y lo suspendió por problemas de tolerabilidad distintos de los asociados con anomalías de la función hepática.
    3. Los sujetos que hayan abandonado previamente el uso de ambrisentán o tadalafilo en otro estudio clínico o como producto comercial (Volibris/Letairis o Adcirca) por motivos de seguridad o tolerabilidad.
    4. El sujeto tiene una hipersensibilidad conocida a los productos en investigación, los metabolitos o los excipientes de la formulación
    5. El sujeto ha recibido inotropos por vía IV en las 2 semanas previas a la visita de selección (p. ej., dopamina, dobutamina)
    6. El sujeto está recibiendo tratamiento con un inhibidor potente de la CYP3A4 (p. ej., inhibidores de la proteasa, ketoconazol sistémico o itraconazol sistémico)
    7. El sujeto está recibiendo tratamiento con un inductor potente de la CYP3A4 (p. ej., rifampicina)
    8. Sujetos que hayan recibido antagonistas del calcio o inhibidores de la HMG-CoA reductasa (es decir, astatinas) en dosis inestables en las 4 semanas previas a la visita de selección (para ser elegibles, los sujetos no deberán haber cambiado la dosis <4 semanas antes de la visita de selección)
    9. Sujetos con antecedentes de angina de pecho u otro proceso que se haya tratado con nitratos de acción prolongada o corta <12 semanas antes de la selección
    Valores analíticos en la selección
    10. Sujetos con valores analíticos de ALT o AST en suero > 2 x LSN en la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de valoración de la eficacia es el tiempo hasta el primer episodio de fracaso clínico en la HAP. El tiempo hasta el fracaso clínico se define como el transcurrido desde la aleatorización hasta la primera observación de:
    - Fallecimiento (por cualquier causa)
    - Hospitalización por empeoramiento de la HAP (adjudicado)
    i. Hospitalización no programada por empeoramiento de la HAP
    ii. Trasplante de pulmón o de corazón y pulmón
    iii. Septostomía auricular
    iv. Instauración de tratamiento parenteral con prostanoides
    - Progresión de la enfermedad (adjudicado)
    i. Descenso >15% de la DC6M respecto a la basal combinado con síntomas de clase III o IV de la OMS (en dos visitas clínicas posbasales consecutivas con &#8805;14 días de separación)
    - Respuesta clínica a largo plazo insatisfactoria (adjudicado, todos los criterios exigidos)
    i. Recibiendo tratamiento aleatorizado durante al menos 6 meses
    ii. Descenso de la DC6M respecto a la basal en dos visitas clínicas posbasales consecutivas con &#8805;14 días de separación
    iii. Síntomas sostenidos de clase III o IV de la OMS durante &#8805;6 meses
    Se explorarán el tiempo hasta el empeoramiento clínico (fallecimiento, hospitalización por empeoramiento de la HAP o progresión de la enfermedad) y la supervivencia a largo plazo (tiempo hasta el fallecimiento) como análisis de apoyo del criterio de valoración principal.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2.3Other No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Este es un estudio basado en episodios. En el momento en que se hayan adjudicado 82 episodios del criterio de valoración principal, es decir, 82 sujetos hayan presentado un episodio, se avisará a todos los sujetos para que acudan a una visita de valoración final (VVF) en un plazo máximo de 28 días o en su visita de la semana 24, lo que sea más tarde.
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 2010-06-02. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 352
    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)
    Después del primer cierre de la base de datos, se pedirá a los sujetos que vuelvan para una visita final del estudio en la que se les hará la valoración final y se desenmascarará su tratamiento del estudio. El investigador debe tratar entonces a los sujetos de acuerdo con la mejor asistencia habitual de la que disponga. Se seguirá a los sujetos durante los 30 días siguientes a su última dosis de medicación del estudio.
    El promotor dejará de suministrar ambrisentán o tadalafilo después del final
    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 Decision2010-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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