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    The EU Clinical Trials Register currently displays   40652   clinical trials with a EudraCT protocol, of which   6635   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-021825-11
    Sponsor's Protocol Code Number:AC-052-373
    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:2010-11-12
    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 number2010-021825-11
    A.3Full title of the trial
    Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar
    A.3.2Name or abbreviated title of the trial where available
    FUTURE 3
    A.4.1Sponsor's protocol code numberAC-052-373
    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 SponsorActelion Pharmaceuticals Ltd.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing 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 TRACLEER 62,5 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderACTELION REGISTRATION LIMITED
    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/3/01/019
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Dispersible 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 INNBOSENTAN MONOHIDRATO
    D.3.9.3Other descriptive nameBOSENTAN MONOHIDRATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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
    Hpertensión arterial pulmonar (PAH) en niños
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064908
    E.1.2Term Associated with (APAH)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064909
    E.1.2Term Idiopathic (IPAH)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064910
    E.1.2Term Familial (FPAH)
    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 es investigar la PK de la formulación pediátrica de bosentan en las dosis de 2 mg/kg b.i.d. y 2 mg/kg t.i.d. en niños con PAH de edad desde &#8805; 3 meses hasta < 12 años.
    E.2.2Secondary objectives of the trial
    Los objetivos adicionales son evaluar la eficacia, tolerabilidad, y seguridad de bosentan en niños con PAH de edad desde &#8805; 3 meses hasta < 12 años.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Diagnóstico de PAH confirmado con RHC:
    a.PAH idiopática o hereditaria, o
    b.PAH asociada persistente tras reparación completa de un defecto cardiaco congénito (la PAH tiene que ser persistente durante al menos 6 meses después de la cirugía).
    2.Clase funcional I, II o III de la WHO (Ver Apéndice 1).
    3. Hombre o mujer &#8805; 3 meses y < 12 años de edad (la edad máxima en la aleatorización es de 11.5 años).
    4. Peso corporal &#8805; 3.5 kg.
    5. Saturación periférica de oxígeno (SpO2) &#8805; 88% (en descanso, en aire ambiental).
    6. Si tiene terapia basal para PAH (bloqueantes de los canales de calcio, bosentan, prostanoides intravenosos o inhalados, inhibidor de la PDE-5), tiene que estar estable durante al menos 3 meses antes de la selección.
    Durante el estudio, todos los tratamientos de base deben permanecer estables.
    7. Consentimiento informado firmado por los padres o representantes legales.
    E.4Principal exclusion criteria
    1. Otras etiologías de la PAH distintas de las enumeradas más arriba.
    2. Estado de la enfermedad no estable, ejem., historia de (cerca-) síncope recurrente o signos y síntomas de fallo de corazón derecho no compensado.
    3. Necesidad o plan de quitar al paciente el epoprostenol intravenoso o iloprost intravenoso o inhalado.
    4. Presión arterial sistólica < 80% del límite inferior del valor normal.
    5. Valores de la AST y/o ALT > 1.5 veces el límite superior del valor normal.
    6. Lesión hepática moderada a grave, es decir de la clase Child-Pugh, B ó C.
    7. Niveles de hemoglobina y/o hematocrito < 75% del límite inferior del valor normal.
    8. Intolerancia o hipersensibilidad conocida a bosentan o a cualquiera de los excipientes del comprimido dispersable de Tracleer.
    9. Tratamiento con medicación prohibida dentro de 2 semanas o al menos 5 veces la semivida antes de la aleatorización, lo que sea más largo:
    ­ Glibenclamida (gliburida)
    ­ Ciclosporina A
    ­ Sirolimus
    ­ Tacrolimus
    ­ Fluconazol
    ­ Rifampicina (rifampin)
    ­ Ritonavir
    ­ Administración conjunta de inhibidores de la CYP2C9 (ejem., amiodarona, voriconazol) e inhibidores moderados/intensos de la CYP3A4 (ejem., amprenavir, eritromicina, ketoconazol, diltiazem, itraconazol)
    ­ Antagonistas del receptor de la endotelina (ERAs) distintos a bosentan
    10. Tratamiento con otro fármaco en investigación dentro de 1 mes antes de la aleatorización o tratamiento planeado.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal de PK se define como la exposición diaria a bosentan, es decir, AUC sobre un periodo de 24 h (AUC0-24h), y calculado como un múltiple de la exposición sobre un intervalo de dosis (AUC&#61556;), 3 × AUC&#61556; y 2 × AUC&#61556; durante la dosificación diaria de tres veces y dos veces, respectivamente.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerabilidad
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    El Final del Estudio se define como la fecha en la cual el último paciente aleatorizado, no discontinuado prematuramente, completa el tratamiento de 24 semanas y el periodo de seguimiento de AE de 7 días.
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    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 2010-11-12. 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
    Un paciente pediátrico es incapaz de proporcionar el consentimiento Informado. Por lo tanto, se debe obtener un completo consentimiento informado de los padres o representantes legales de acuerdo con las leyes o regulaciones nacionales.
    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 20
    F.4.2.2In the whole clinical trial 64
    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)
    Para los pacientes que completen la visita de Final del Estudio mientras continua con el tratamiento con bosentan, estará disponible la participación en un estudio de extensión de 1 año de duración bajo un protocolo separado. Los pacientes que no entren en la extensión tendrán un seguimiento post-tratamiento de 60 días.
    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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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