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    Summary
    EudraCT Number:2016-001062-28
    Sponsor's Protocol Code Number:AC-055-312
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-13
    Trial 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 number2016-001062-28
    A.3Full title of the trial
    A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension
    Estudio multicéntrico, abierto, aleatorizado, basado en acontecimientos, para evaluar la eficacia, la seguridad y la farmacocinética de macitentán frente al tratamiento de referencia en niños con hipertensión arterial pulmonar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)
    Un estudio para evaluar si el fármaco macitentán actua en niños con hipertensión arterial pulmonar (HAP)
    A.3.2Name or abbreviated title of the trial where available
    TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide
    A.4.1Sponsor's protocol code numberAC-055-312
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/049/2016
    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 supportACTELION Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical trial disclosure desk
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 900 834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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/3/11/909
    D.3 Description of the IMP
    D.3.1Product namemacitentan
    D.3.2Product code ACT-064992
    D.3.4Pharmaceutical form Dispersible 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 INNMACITENTAN
    D.3.9.1CAS number 441798-33-0
    D.3.9.4EV Substance CodeSUB89247
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) 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/3/11/909
    D.3 Description of the IMP
    D.3.1Product namemacitentan
    D.3.2Product code ACT-064992
    D.3.4Pharmaceutical form Dispersible 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 INNMACITENTAN
    D.3.9.1CAS number 441798-33-0
    D.3.9.4EV Substance CodeSUB89247
    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) 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/3/11/909
    D.3 Description of the IMP
    D.3.1Product namemacitentan
    D.3.2Product code ACT-064992
    D.3.4Pharmaceutical form Dispersible 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 INNMACITENTAN
    D.3.9.1CAS number 441798-33-0
    D.3.9.4EV Substance CodeSUB89247
    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.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
    Pulmonary arterial hypertension
    Hipertensión arterial pulmonar
    E.1.1.1Medical condition in easily understood language
    Pulmonary Arterial Hypertension is a condition in which the pressure in the blood vessels going to the lungs (the pulmonary arteries) is higher than normal
    Hipertensión arterial pulmonar es la codicion en la cual la presion de los vasos sanguineos que van a los pulmones ( arterias pulmonares) es mas alta de lo normal.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate macitentan in comparison to Standard of Care (SoC) with regard to delaying disease progression in children with PAH.
    El objetivo principal del estudio consiste en evaluar macitentán en comparación con el tratamiento de referencia (TR) en lo que respecta al retraso de la progresión de la enfermedad en niños con hipertensión arterial pulmonar (HAP).
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of macitentan in children with PAH.
    To assess PK of macitentan in children with PAH.
    Evaluar la seguridad y la tolerabilidad de macitentán en niños con HAP.
    Evaluar la farmacocinética (FC) de macitentán en niños con HAP.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) Substudy.
    Optional for up to 40 subjects.
    The analysis of the PK sub-study will be used to select the appropriate daily dose in subjects below 2 years of age.
    La participación en el subestudio de farmacocinética será opcional para un máximo de 40 pacientes.
    El análisis del subestudio de farmacocinética se utilizará para seleccionar la dosis diaria apropiada para los sujetos menores de dos años
    E.3Principal inclusion criteria
    1. Signed informed consent by the parent(s) or legally designated representative AND assent from developmentally capable children prior to initiation of any study-mandated procedure.
    2. Males or females between maior an equal to 2 years and minor to 18 years of age.
    3. Subjects with body weight ≥ 10 kg at randomization.
    4. PAH diagnosis, confirmed by historical RHC (mPAP ≥ 25 mmHg, and PAWP ≤ 15 mmHg, and PVRi > 3 WUxm2).
    5. PAH belonging to the Nice 2013 Updated Classification Group 1 (including subjects with Down syndrome) and of following etiologies:
    • iPAH
    • hPAH
    • PAH associated with CHD
    • Drug or toxin induced PAH
    • PAH associated with HIV
    • PAH-aCTD
    6. WHO FC I to III.
    7. Females of childbearing potential must have a negative pregnancy test at Screening and at Baseline, and must agree to undertake monthly pregnancy tests, and to use a reliable method of contraception (if sexually active) up to EOS.
    1.Consentimiento informado firmado por los padres o el representante legal Y asentimiento de los niños capaces desde el punto de vista del desarrollo antes de realizar ningún procedimiento exigido por el estudio.
    2.Sujetos de cualquier sexo con una edad mayor o igual a 2 y menor a 18 años.
    3.Sujetos con un peso corporal mayor oigual a 10 kg en el momento de la aleatorización.
    4.Diagnóstico de HAP menor or igaul a 12 meses antes de la aleatorización, confirmada mediante un cateterismo cardíaco derecho histórico (CCD; caracterizado por una presión arterial pulmonar media mayor o igual a 25 mm Hg, una presión de enclavamiento arterial pulmonar menor o igual a 15 mm Hg y una resistencia vascular pulmonar[iRVP] mayor a 3 unidades Wood x m2)
    5.HAP perteneciente al grupo 1 de la clasificación de Niza actualizada en 2013 (incluido síndrome de Down) y de las siguientes etiologías:
    •HAP idiopática (HAPi).
    •HAP hereditaria (HAPh).
    •HAP asociada a cardiopatía congénita (CC)
    •HAP inducida por drogas o toxinas.
    •HAP asociada al VIH.
    •HAP asociada a enfermedad del tejido conjuntivo (HAP ETC).
    6.Clase funcional I a III de la OMS.
    8. Las pacientes en edad fértil deberán tener una prueba de embarazo negativa en la selección y el momento basal, así como comprometerse a someterse a pruebas de embarazo mensuales y a utilizar un método anticonceptivo fiable (en caso de ser sexualmente activas) hasta el FDE
    E.4Principal exclusion criteria
    1. Subjects with PAH due to portal hypertension, schistosomiasis, or with pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn.
    2. Subjects with PAH associated with Eisenmenger syndrome, or with moderate tolarge left-to right shunts
    3. Subjects receiving a combination of > 2 PAH-specific treatments at randomization.
    4. Treatment with i.v. or s.c. prostanoids within 4 weeks before randomization, unless given for vasoreactivity testing.
    5. Hemoglobin or hematocrit <75% of the lower limit of normal range
    6. Serum AST and/or ALT > 3 times the upper limit of normal range'
    7. Pregnancy (including family planning) or breastfeeding.
    8. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
    1.Sujetos con HAP debida a hipertensión portal, esquistosomiasis, enfermedad venooclusiva pulmonary/o hemangiomatosis capilar pulmonar y hipertensión pulmonar persistente del neonato.
    Tratamiento e intervención
    2.Sujetos con HAP asociada a sindrome de Eisenmenger o con cortocircuitos izquierda-derecha abiertos de moderados a grandes.
    3. Sujetos que estén recibiendo una combinación de más de dos tratamientos específicos para la HAP en el momento de la aleatorización.
    4.Tratamiento con prostanoides IV o SC en las cuatro semanas previas a la aleatorización, a menos que se hayan administrado para estudiar la vasorreactividad
    5. Hemoglobina o hematocritomenor a 75% del límite inferior del intervalo normal.
    6.Concentración de aspartato aminotransferasa y/o alanina aminotransferasa en suero mayor a 3 veces el límite superior del intervalo normal.
    7.Embarazo (incluida planificación familiar) o lactancia
    8.Abuso de drogas o sustancias psicoactivas o cualquier trastorno que, en opinión del investigador, pueda impedir el cumplimiento del protocolo o del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to the first of the following CEC-confirmed disease progression events occurring between randomization and EOS:
    • Death (all causes)
    • Atrial septostomy or Potts’ anastomosis, or registration on lung transplant list
    • Hospitalization due to worsening PAH
    • Clinical worsening of PAH
    El criterio de valoración principal de la eficacia será el tiempo transcurrido hasta que se produzca el primero de los siguientes acontecimientos de progresión de la enfermedad confirmados por el CAC entre la aleatorización y el final del estudio:
    •Muerte (por cualquier causa).
    •Septostomía auricular o anastomosis de Potts, o inscripción en la lista de espera para un trasplante de pulmón.
    •Hospitalización por empeoramiento de la HAP§.
    •Empeoramiento clínico de la HAP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between randomization and End-of-Study (EOS)
    Entre la aleatorización y el fin de estudio
    E.5.2Secondary end point(s)
    The secondary endpoints are analyzed in the following hierarchical order:
    • Time to first CEC-confirmed hospitalization for PAH occurring between randomization and EOS.
    • Time to CEC-confirmed death due to PAH occurring between randomization and EOS.
    • Time to death (all causes) occurring between randomization and Study Closure.
    Los criterios de valoración secundarios serán:
    •Tiempo transcurrido hasta la primera hospitalización por HAP confirmada por el CAC que se produzca entre la aleatorización y el final del estudio.
    •Tiempo transcurrido hasta la muerte por HAP confirmada por el CAC que se produzca entre la aleatorización y el final del estudio.
    •Tiempo transcurrido hasta la muerte (por cualquier causa) que se produzca entre la aleatorización y el cierre del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between randomization and End-of-Study (EOS)
    Entre la aleatorización y el fin de estudio
    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 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 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
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Argentina
    Australia
    Austria
    Bulgaria
    Canada
    China
    France
    Germany
    Hungary
    Israel
    Korea, Republic of
    Mexico
    Philippines
    Poland
    Portugal
    Russian Federation
    South Africa
    Spain
    Thailand
    Ukraine
    United States
    Vietnam
    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
    The study is considered completed when the last subject completes the study (i.e. last EOS visit or last safety follow-up contact, whichever occurs last)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 300
    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: 220
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who cannot give assent (below 7 years of age) will be included. In general, the majority of patients will not give consent but only assent.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 300
    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)
    Participation to a study extension under a separate study protocol will be proposed at EOS after announcement of Study Closure if applicable
    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 Decision2017-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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