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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   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:2011-003310-17
    Sponsor's Protocol Code Number:AC-063B201
    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:2011-09-28
    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 number2011-003310-17
    A.3Full title of the trial
    "Estudio fase II, multicentrico, doble ciego, randomizado, controlado con placebo para evaluar los efectos de IIoprost inhalado en una prueba de resistencia durante un test de ejercicio cardiopulmonar en pacientes con hipertension pulmonar secundaria a enfermedad obstructiva pulmonar cronica"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of endurance time before and after treatment with inhaled
    Iloprost in patients with elevated blood pressure in the lungs
    (Pulmonary Hypertension) secondary to chronic lung disease (Chronic
    Obstructive Pulmonary Disease)
    A.4.1Sponsor's protocol code numberAC-063B201
    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 Pharmaceuticals Ltd.
    B.5.2Functional name of contact pointGLOBAL MEDICAL INFORMATION
    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.5.6E-mailmedinfo@actelion.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 Yes
    D.2.1.1.1Trade name VENTAVIS
    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 nameInhaled Iloprost (20 ?g/mL Solution)
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNILOPROST
    D.3.9.1CAS number 78919-13-8
    D.3.9.4EV Substance CodeSUB08136MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hipertension pulmonar secundaria a enfermedad obstructiva pulmonar cronica

    Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease
    E.1.1.1Medical condition in easily understood language
    Tension arterial elevada en los pulmones (Hipertension pulmonar) en pacientes con enfermedad pulmonar cronica (enfermedad pulmonar obstructiva cronica)
    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 LLT
    E.1.2Classification code 10037406
    E.1.2Term Pulmonary hypertension secondary
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10010953
    E.1.2Term COPD exacerbation
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el efecto de iloprost inhalado en el tiempo de resistencia al ejercicio, en comparación con el placebo, durante las pruebas de ejercicio cardiopulmonar (PECP) a un ritmo de trabajo constante al final de la semana 4.
    E.2.2Secondary objectives of the trial
    ? Evaluar la respuesta hemodinámica aguda a una única dosis de iloprost inhalado, en comparación con el placebo, durante el cateterismo cardiaco derecho (CCD).
    ? Evaluar los efectos de iloprost inhalado, en comparación con el placebo, al final de la semana 4 en el intercambio gaseoso pulmonar y otras medidas de la eficacia.
    ? Evaluar la seguridad y la tolerabilidad de iloprost inhalado en comparación con el placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Etapa 1: Selección inicial
    1. Consentimiento informado firmado antes de iniciar cualquier procedimiento obligatorio del estudio
    2. Hombre o mujer ? 40 y ? 75 años
    3. Las mujeres en edad fértil deben utilizar un método anticonceptivo fiable (índice de error menor del 1% al año) desde la selección hasta 1 mes después de finalizar el medicamento del estudio
    4. Diagnóstico clínico de EPOC de moderada a severa, con un patrón obstructivo en las pruebas de la función pulmonar que muestre:
    1. FEV1/CVF < 0,7 y
    2. 30% del valor predicho ? FEV1 ? 60% del valor predicho, en tratamiento estándar para EPOC
    5. DLCO < 60% del valor predicho
    6. PaO2 > 55 mmHg en descanso sin oxígeno
    7. Fracción de eyección del ventrículo izquierdo ? 50%
    8. Fumadores o exfumadores de ? 10 años paquete
    9. En caso de tomar corticoesteroides orales (< 20 mg/día del equivalente a la prednisona) o inhalados, agonistas beta inhalados (de acción corta o prolongada), o antagonistas muscarínicos inhalados (de acción corta o prolongada), o estatinas, la dosis debe ser estable desde al menos 30 días antes de la visita del CCD
    10. Capacidad para realizar las pruebas de ejercicio sin suplemento de oxígeno (según el mejor criterio del investigador)
    11. En caso de tratamiento prolongado con oxígeno, la velocidad de flujo de O2 debe ser < 4 L/min

    Solo para los pacientes que cumplan todos los criterios de inclusión de la etapa 1 y ninguno de los criterios de exclusión:
    Etapa 2: Selección mediante ecocardiografía central:
    1. Sospecha de hipertensión pulmonar en la lectura de la ecocardiografía central.

    Solo para los pacientes que cumplan los criterios de la etapa 2:
    Etapa 3: Cateterismo cardiaco derecho (CCD)
    Los pacientes serán elegibles para el estudio si el CCD realizado en el día 1 muestra:
    1. Presión arterial pulmonar media (PAPm) ? 25 mmHg en descanso y
    2. Presión capilar pulmonar en cuña (PCPC) ? 15 mmHg
    E.4Principal exclusion criteria
    1. Los pacientes que cumplan uno o más de los siguientes criterios de exacerbación documentada de la EPOC en los 2 meses anteriores a la selección:
    - Uso de antibióticos para la exacerbación de la EPOC
    - Iniciación o aumento de la dosis de corticoesteroides (inhalados, orales o intravenosos) para la exacerbación de la EPOC
    - Hospitalización por la exacerbación de la EPOC
    2. Otras causas de hipertensión pulmonar que no sean EPOC
    3. IMC > 35 kg/m2
    4. Patologías que se consideren contraindicaciones para las PECP y/o incapacidad de pedalear sobre un cicloergómetro
    5. Enfermedad arterial coronaria inestable, angina inestable o infarto de miocardio en los 3 meses anteriores a la selección
    6. Antecedentes de edema pulmonar, o insuficiencia cardiaca no controlada
    7. Hipertensión sistémica no controlada con una tensión arterial >180/105 mmHg en descanso
    8. Hipotensión sistémica con tensión arterial sistólica < 85 mmHg
    9. Arritmias no controladas
    10. Antecedentes de síncope
    11. Intervención quirúrgica programada durante el periodo del estudio
    12. Cualquier factor o enfermedad conocidos que puedan interferir con el cumplimiento terapéutico, realización del estudio o interpretación de los resultados, entre ellos las limitaciones musculoesqueléticas, la enfermedad arterial periférica, la drogodependencia o el alcoholismo o la enfermedad psiquiátrica
    13. Deficiencia de hierro (ferritina sérica <10 ng/ml)
    14. Hemoglobina en sangre (Hb) < 9 g/dl o > 22 g/dl
    15. Insuficiencia hepática de moderada a severa (Child-Pugh Clase B o C)
    16. Insuficiencia renal crónica, definida mediante creatinina sérica > 2,5 mg/dl o aclaramiento de la creatinina estimado < 30 ml/min o necesidad de diálisis
    17. Embarazo o lactancia
    18. Toma en la actualidad (en los 30 días anteriores a la visita del CCD) tratamiento específico para la hipertensión arterial pulmonar (por ej.: bosentán, ambrisentán, tadalafilo, sildenafilo, epoprostenol, treprostinilo, iloprost, beraprost)
    19. Iniciación de un programa de rehabilitación pulmonar en los 3 meses anteriores a la selección o iniciación o cambios durante el estudio
    20. Participación en otro ensayo clínico, excepto un estudio observacional, o haber recibido un medicamento en investigación en los 30 días anteriores a la visita del CCD
    21. Enfermedad potencialmente mortal concomitante conocida con una esperanza de vida < 12 meses
    22. Hipersensibilidad conocida a iloprost o a cualquiera de los excipientes de las formulaciones de los medicamentos.
    E.5 End points
    E.5.1Primary end point(s)
    ? Cambio desde el valor basal hasta la semana 4 en el tiempo de resistencia durante las PECP a un ritmo de trabajo constante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Desde la basal a la semana 4
    E.5.2Secondary end point(s)
    Cambio desde el valor basal hasta la semana 4 en:
    o la escala de disnea modificada del MRC
    o la clasificación de la disnea de Borg
    o Función pulmonar (es decir, CVF, FEV1, FEV1/CVF, CV, CPT y DLCO)
    o péptido natriurético cerebral N-terminal en plasma (NT pro-BNP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Por favor, vease el protocolo
    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 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
    Tolerability
    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) 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA2
    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
    France
    Spain
    United States
    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
    El final del estudio es definido como el ultimo paciente, ultima visita en la semana 4.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 76
    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)
    Seguimiento de seguridad: 30 dias despues de la finalizacion de la medicacion del estudio

    Safety follow-up: 30 days after the end of study medication (telephone call).
    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 Decision2011-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-30
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