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    The EU Clinical Trials Register currently displays   37989   clinical trials with a EudraCT protocol, of which   6231   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-018322-40
    Sponsor's Protocol Code Number:AC-066A301
    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:2011-11-03
    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 number2010-018322-40
    A.3Full title of the trial
    Estudio de fase 3b multicéntrico, de una única rama, abierto para evaluar los efectos de cambiar de Flolan® a ACT-385781A en pacientes con hipertensión arterial pulmonar // A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio de investigación clínica para evaluar la seguridad de cambiar el Flolan por un nuevo fármaco llamado Epoprostenol-Actelion en pacientes que padecen hipertensión arterial pulmonar
    A.3.2Name or abbreviated title of the trial where available
    EPITOME-2
    A.4.1Sponsor's protocol code numberAC-066A301
    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 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 REgistration Ltd
    B.5.2Functional name of contact pointGlobal Medical Information
    B.5.3 Address:
    B.5.3.1Street Address389 Chiswick High Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codew4 4AL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+41615656790
    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 Epoprostenol for injection
    D.2.1.1.2Name of the Marketing Authorisation holderActelion Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEpoprostenol for injection
    D.3.2Product code ACT-385781A
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPOPROSTENOL SODICO
    D.3.9.1CAS number 61849-14-7
    D.3.9.3Other descriptive nameEPOPROSTENOL SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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 RoleComparator
    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 Epoprostenol for injection
    D.2.1.1.2Name of the Marketing Authorisation holderActelion Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEpoprostenol for injection
    D.3.2Product code ACT-385781A
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPOPROSTENOL SODICO
    D.3.9.1CAS number 61849-14-7
    D.3.9.3Other descriptive nameEPOPROSTENOL SODIUM
    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.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 (HAP)
    E.1.1.1Medical condition in easily understood language
    La Hipertensión Arterial Pulmonar (HAP) es una situación en la que la presión en los vasos sanguineos que van a los pulmones (las arterias pulmonares) es superior a la 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 14.0
    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
    - Evaluar el cambio en la hemodinámica cardiaca desde el nivel inicial hasta 3 meses tras el cambio de Flolan a epoprostenol para inyección en pacientes con hipertensión arterial pulmonar (HAP).
    - Evaluar la seguridad y tolerancia del cambio de Flolan a epoprostenol para inyección en pacientes con HAP.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombre o mujer de 18 años de edad y más
    2. Pacientes con los siguientes tipos de hipertensión arterial pulmonar (HAP) pertenecientes al grupo I de la OMS:
    Idiopática (HAPI)
    Hereditaria (HAPH)
    Asociada (HAPA) con
    o Enfermedades del tejido conjuntivo
    o Drogas y toxinas
    3. Pacientes tratados con Flolan durante al menos 12 meses y con una dosis estable durante al menos 3 meses antes de la inclusión
    4. Los pacientes que reciben tratamiento actualmente con terapia concomitante para HAP indicada a continuación deben haberse tratado durante al menos 90 días y con una dosis estable durante 30 días antes de la inclusión:
    Bosentan
    Ambrisentan
    Sitaxentan
    Sildenafilo
    Tadalafilo
    5. Las mujeres fértiles deben usar un método anticonceptivo fiable
    6. Consentimiento informado firmado antes del inicio de cualquier procedimiento obligado por el estudio
    E.4Principal exclusion criteria
    1. Pacientes con dificultad respiratoria y/o cardiovascular que necesitan cuidados de urgencia
    2. Conocimiento o sospecha de enfermedad venooclusiva pulmonar (EVOP)
    3. Uso actual de agentes inotrópicos i.v.
    4. Uso actual de cualquier prostaciclina o análogo de prostaciclina distinto de Flolan
    5. Taquicardia con frecuencia cardiaca > 120 latidos/min en reposo
    6. HAP relacionada con cualquier estado distinto de los especificados en los criterios de inclusión
    7. Hipersensibilidad conocida a las formulaciones de epoprostenol para inyección o cualquiera de sus excipientes, y Flolan o cualquiera de sus excipientes
    8. Acontecimientos cerebrovasculares (por ejemplo, accidente cerebrovascular o ataque isquémico transitorio) en el plazo de 6 meses desde la selección
    9. Historia de infarto de miocardio
    10. Historia de cardiopatía de lado izquierdo, incluyendo cualquiera de lo siguiente:
    enfermedad de válvula mitral o aórtica hemodinámicamente significativa
    miocardiopatía restrictiva o congestiva
    fracción de eyección del ventrículo izquierdo < 40% mediante angiograma de equilibrio con radionúclidos (MUGA), angiografía, o ecocardiografía
    angina de pecho inestable
    arritmias cardiacas potencialmente mortales
    11. Trastornos hemorrágicos crónicos
    12. Infección de la vía venosa central en el plazo de 90 días antes de la selección y/o historia de infecciones de vía recurrentes
    13. Mujeres que están embarazadas o en periodo de lactancia
    14. Participación en otro ensayo clínico, excepto observacional, o recepción de un producto en investigación en el plazo de 30 días antes de la inclusión
    15. Cualquier enfermedad o factor conocido que pudiera interferir con el cumplimiento con el tratamiento, la realización del estudio o la interpretación de los resultados tales como drogodependencia o alcoholismo o enfermedad psiquiátrica
    16. Enfermedad potencialmente mortal concomitante conocida distinta de HAP con una esperanza de vida < 12 meses
    E.5 End points
    E.5.1Primary end point(s)
    Tolerancia y Seguridad
    - Acontecimientos adversos (AA) que surgen con el tratamiento hasta 24 horas tras el EOT
    -Cambio desde el nivel inicial hasta el EOT en los signos vitales [frecuencia cardiaca (FC) y tensión arterial (TA)] y peso corporal
    -AA que conducen a detención prematura del fármaco del estudio
    -AA graves (AAG) que surgen con el tratamiento hasta 30 días tras el EOT

    Eficacia:
    Cambio desde el nivel inicial hasta el EOT en la hemodinámica cardiaca incluyendo:
    o Resistencia vascular pulmonar (RVP)
    o Presión arterial pulmonar media (PAPm)
    o Presión de la aurícula derecha (PAD)
    o Presión de oclusión de la arteria pulmonar (POAP)
    o Índice cardiaco (IC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Visitas telefónicas semanales: Semanas 1, 2 y 3
    - Visita hospitalaria : Semana 4
    - Visita telefónica quicenal: Semanas 6, 8 y 10

    Seguimiento seguridad:
    - Llamada telefónica 24 horas después de la visita de EOT
    - Llamada telefónica 30 días después de la visita de EOT

    Fin de estudio:
    - 24 horas después de la llamada telefónica del EOT en pacientes que participen en en estudio de extensión AC-066A302
    - 30 días después de la llamada telefónica del EOT en pacientes que NO participen en en estudio de extensión AC-066A302
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerabilidad, estudio exploratorio fase 3b
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Belgium
    Canada
    France
    Italy
    Netherlands
    Spain
    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
    Última Visita de Fin de Tratamiento del Útimo Paciente (LPLETV; Last Patient Last End of Treatment Visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 35
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 35
    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)
    NA
    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 Decision2011-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
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