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    Summary
    EudraCT Number:2012-001642-17
    Sponsor's Protocol Code Number:AMB116457
    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:2013-03-06
    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 number2012-001642-17
    A.3Full title of the trial
    An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Estudio de extensión abierto sobre la seguridad, tolerabilidad y eficacia a largo plazo de ambrisentan en sujetos con hipertensión pulmonar tromboembólica crónica (HPTEC) no operable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
    Estudio de extensión de un medicamenteo para el tratamiento de la hipertensión pulmonar tromboembólica crónica (HPTEC) no operable.
    A.4.1Sponsor's protocol code numberAMB116457
    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 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 supportGSK Pharma and R&D
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 4466
    B.5.5Fax number+442081234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Volibris
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameGSK1325760
    D.3.2Product code GSK1325760
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 177036-94-1
    D.3.9.2Current sponsor codeGSK1325760
    D.3.9.3Other descriptive nameambrisentan
    D.3.9.4EV Substance CodeSUB25424
    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
    Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    Sujetos con hipertensión pulmonar tromboembólica crónica (HPTEC) no operable.
    E.1.1.1Medical condition in easily understood language
    Inoperable chronic thromboembolic pulmonary hypertension.
    Hipertensión pulmonar tromboembólica crónica no operable.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10068739
    E.1.2Term Chronic thromboembolic pulmonary hypertension
    E.1.2System Organ Class 100000004855
    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 is the long-term safety and tolerability of ambrisentan in the CTEPH population (see Safety).
    - Safety assessments:
    - Adverse Events;
    - Serious Adverse Events;
    - Clinical laboratory parameters (including liver safety and haematological parameters);
    - Physical examination (including jugular venous pressure, liver size, peripheral oedema, ascites and signs of deep vein thrombosis);
    - Vital Signs (including body mass index at the entry visit only);
    The time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to tolerability issues (e.g. adverse events).
    El objetivo principal de este estudio consiste en evaluar la eficacia y tolerabilidad de ambrisentan a largo plazo en la población con HPTEC (véase Seguridad).
    Seguridad:
    - Acontecimientos adversos;
    - acontecimientos adversos graves;
    - parámetros analíticos clínicos (tales como seguridad hepática y parámetros hematológicos);
    - exploración física (como presión venosa yugular, tamaño del hígado, edema periférico, ascitis y signos de trombosis venosa profunda);
    - constantes vitales (incluyendo índice de masa corporal solo en la visita de inclusión);
    - tiempo hasta el cambio de la dosis de ambrisentan u otros agentes terapéuticos dirigidos contra HAP (prostanoides, inhibidores de PDE-5) debido a problemas de tolerabilidad (p. ej., acontecimientos adversos).
    E.2.2Secondary objectives of the trial
    Efficacy assessments
    - 6 minute walking distance (6MWD) test evaluated every three months;
    - WHO functional class every three months;
    - Borg CR10 Scale (BCR10S) immediately following exercise, every three months;
    - Clinical worsening of CTEPH as defined by the time from randomization to the first occurrence of
    - Death
    - lung transplantation
    - hospitalization for worsening CTEPH
    - atrial septostomy
    - addition parenteral prostanois
    - appearance of two or more CTEPH worsening events*] (TTCW);

    For further information please view section 2.2.1 of the protocol
    Eficacia
    - El cambio del test de la marcha de 6 minutos (TM6M) desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses;
    - el cambio de la clase funcional de la OMS desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses;
    - el cambio de la escala CR10 de Borg (ECR10B) inmediatamente después del ejercicio desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses;
    - empeoramiento clínico de la HPTEC, que se define como el tiempo desde la aleatorización hasta la primera ocurrencia de
    Muerte; trasplante de pulmón; hospitalización a causa de empeoramiento de la HPTEC; septostomía atrial; adición de prostanoides parenterales; aparición de dos o más acontecimientos de empeoramiento de la HPTEC

    Par más información ver el Apartado 2.2.1 del Protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    Have been randomized to the protocol for AMB115811 and have met one of the following:
    a) Completed the Week 16 visit in AMB115811;
    b) Prematurely withdrew from AMB115811 for whatever reason*
    *where IP has been stopped due to safety or efficacy reasons, the subject may still enter into the open label study regardless of what treatment they are receiving (other treatments will not be supplied by the sponsor) but will not be permitted to receive IP.
    Subject is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study
    treatment that may impact subject eligibility is provided in the Investigators Brochure and product label for PAH indication.
    Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore,
    adherence to the criteria as specified in the protocol is essential.

    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    Los sujetos elegibles para su inclusión en el estudio deben cumplir todos los criterios que se enumeran a continuación:
    Se han aleatorizado según el protocolo de AMB115811 y cumplen uno de los siguientes criterios:
    a) Completaron la visita de la semana 16 en AMB115811;
    b) abandonaron el AMB115811 de forma prematura (prematurely withdrew) por cualquier razón*.
    *cuando se ha interrumpido la administración del PI por motivos de seguridad o eficacia, el sujeto seguirá pudiendo entrar en el estudio abierto independientemente del tratamiento que esté recibiendo (el promotor no suministrará otros tratamientos) pero no se le permitirá tomar el PI.

    El sujeto está capacitado y dispuesto a proporcionar su consentimiento informado por escrito. Como parte del consentimiento, se informará a las pacientes en edad fértil de los riesgos de teratogenicidad y será necesario aconsejarles de manera apropiada sobre la importancia de la prevención del embarazo. Asimismo, se informará a los sujetos varones de los posibles riesgos de atrofia tubular testicular y aspermia.

    En el Manual del investigador y la ficha técnica del producto indicado para la HAP se proporciona la información específica respecto a las advertencias, precauciones, contraindicaciones, acontecimientos adversos y otra información pertinente sobre el producto en investigación de GSK que puedan tener influencia sobre la elegibilidad de los sujetos.

    No se permiten excepciones o desviaciones de los criterios de inclusión ya que potencialmente pueden poner en peligro la integridad científica del estudio, la aceptación por las agencias reguladoras o la seguridad del paciente. Por tanto, es fundamental adherirse a los criterios tal y como se especifican en el protocolo.

    Sujetos franceses: en Francia, únicamente los sujetos afiliados o beneficiarios de una categoría de la Seguridad Social se considerarán elegibles para la inclusión en este estudio.
    E.4Principal exclusion criteria
    Exclusion from IP
    Subjects meeting any of the following criteria must not receive ambrisentan, however may still be followed-up as part of the study and be treated according to best clinical practice as decided by the investigator:
    1. Subject has a known hypersensitivity to the Investigational Products, the metabolites, or formulation excipients
    2. Female subjects who are pregnant or breastfeeding or no-longer agree to comply with using effective contraception as defined in Appendix 2
    3. Subjects with ALT and/or AST >= 3xULN
    4. Subjects with bilirubin >= 2xULN (>35% direct bilirubin)
    5. Subjects with severe renal impairment (estimated creatinine clearance <30 mL/min assessed within the previous 45 days) at the point of transition from Study AMB115811
    6. Subject has moderate - severe hepatic impairment (Child-Pugh class B-C with or without cirrhosis) at the point of transition from study AMB115811
    7. Subject with clinically significant fluid retention in the opinion of the investigator
    8. Subject with clinically significant anemia in the opinion of the investigator
    9. Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB115811.

    Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    Exclusión del IP: Los sujetos que cumplan cualquiera de los siguientes criterios no recibirán ambrisentan, no obstante, se les puede seguir realizando el seguimiento como parte del estudio y tratar de acuerdo a las mejores prácticas clínicas según decisión del investigador:
    1. El sujeto presenta hipersensibilidad conocida a los productos en investigación, metabolitos o excipientes de la formulación.
    2. Las pacientes están embarazadas, en periodo de lactancia o ya no aceptan cumplir con la condición de utilizar métodos anticonceptivos eficaces tal y como se expone en el Apéndice 2.
    3. Sujetos con ALT y/o AST >=3 x LSN.
    4. Sujetos con bilirrubina >=2 x LSN (> 35% bilirrubina directa).
    5. Sujetos que presenten insuficiencia renal grave (aclaramiento de creatinina estimada < 30 ml/min evaluado en los 45 días anteriores) en el punto de transición del estudio AMB115811.
    6. El sujeto presenta insuficiencia hepática moderada - grave (categoría B-C según la clasificación Child-Pugh con o sin cirrosis) en el punto de transición del estudio AMB115811.
    7. El sujeto presenta retención de fluidos clínicamente significativa según la opinión del investigador.
    8. El sujeto presenta anemia clínicamente significativa según la opinión del investigador.
    9. El sujeto va a iniciar otro ensayo clínico o tomar otro producto en investigación después de finalizar el estudio AMB115811.
    No se permiten excepciones o desviaciones de los criterios de exclusión ya que potencialmente pueden poner en peligro la integridad científica del estudio, la aceptación por las agencias reguladoras o la seguridad del paciente. Por tanto, es fundamental adherirse a los criterios tal y como se especifican en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is the long-term safety and tolerability of ambrisentan in the CTEPH population.
    El objetivo principal de este estudio consiste en evaluar la eficacia y tolerabilidad de ambrisentan a largo plazo en sujetos con HPTEC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Entry in the study, monthly, every 3 months, every 6 months and follow-up visits
    Al entrar en el ensayo, mensualmente, cada 3 meses, cada 6 meses y en las visitas de seguimiento.
    E.5.2Secondary end point(s)
    Efficacy:

    - The change from Study AMB115811 baseline and week 16 visits in the 6 minute walking distance (6MWD) test evaluated every three months;
    - The change from Study AMB115811 baseline and week 16 visits in WHO functional class every three months;
    - The change from Study AMB115811 baseline and week 16 visits in Borg CR10 Scale (BCR10S) immediately following exercise, every three months;
    - Clinical worsening of CTEPH as defined by the time from randomization to the first occurrence of
    - Death
    - lung transplantation
    - hospitalization for worsening CTEPH
    - atrial septostomy
    - addition of parenteral prostanoids
    - appearance of two or more CTEPH worsening events*;
    *Worsening events to consider:
    1. A decrease from baseline of at least 20 percent in the distance walked during the six-minute walk test;
    2. An increase of one or more WHO Functional Class;
    3. Worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure, new/worsening hepatomegaly, ascites, or peripheral edema);
    4. Rapidly progressing cardiogenic, hepatic, or renal failure;
    5. Refractory systolic hypotension (systolic blood pressure less than 85 mmHg).
    Clinical Worsening events will be independently adjudicated.
    - The time to addition of another targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to the following reasons:
    ­ · Deterioration of clinical condition;
    ­ · Lack of beneficial effect with previous therapy (not reaching set treatment goals);
    - The time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to deterioration of clinical condition;
    - The change from Study AMB115811 baseline and week 16 visits in Subject Global Assessment every three months using the Short Form 36 Health Survey (SF-36)
    - Change from Study AMB115811 baseline and week 16 visits in N-terminal pro-B-type natriuretic peptide (NT-Pro BNP) concentration every three months.
    Other
    - The change from Study AMB115811 baseline and week 16 visits cardiopulmonary hemodynamic assessments data in subjects in whom hemodynamic data is considered part of the standard of care
    Eficacia

    - El cambio del test de la marcha de 6 minutos (TM6M) desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses;
    - el cambio de la clase funcional de la OMS desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses;
    - el cambio de la escala CR10 de Borg (ECR10B) inmediatamente después del ejercicio desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses;
    - empeoramiento clínico de la HPTEC, que se define como el tiempo desde la aleatorización hasta la primera ocurrencia de
    · muerte
    · trasplante de pulmón
    · hospitalización a causa de empeoramiento de la HPTEC
    · septostomía atrial
    · adición de prostanoides parenterales
    · aparición de dos o más acontecimientos de empeoramiento de la HPTEC*.
    *Acontecimientos de empeoramiento a considerar:
    1. Una disminución en relación al valor basal de al menos un 20% en la distancia recorrida durante el test de la marcha de seis minutos;
    2. un aumento de una o más clases funcionales de la OMS;
    3. empeoramiento de la disfunción ventricular derecha (p. ej., según lo indicado por el aumento de la presión venosa yugular, hepatomegalia nueva/con empeoramiento, ascitis o edema periférico; empeoramiento de los parámetros ecocardiográficos tales como el desplazamiento sistólico del plano del anillo tricuspídeo (TAPSE, por sus siglas en inglés) e IDT del anillo tricuspídeo);
    4. insuficiencia renal, hepática o cardiaca rápidamente progresiva;
    5. hipotensión sistólica refractaria (tensión arterial sistólica inferior a 85 mmHg).
    Los acontecimientos de empeoramiento clínico se adjudicarán independientemente.
    - Tiempo hasta la adición de otros agentes terapéuticos dirigidos contra HAP (prostanoides, inhibidores de PDE-5) por los siguientes motivos:
    ­Deterioro del estado clínico;
    falta de un efecto beneficioso con tratamiento previo (sin alcanzar los objetivos de tratamiento fijados).
    - Tiempo hasta el cambio en la dosis de ambrisentan u otros agentes terapéuticos dirigidos contra HAP (prostanoides, inhibidores de PDE-5) debido al deterioro del estado clínico.
    - El cambio de la valoración global del sujeto utilizando el Cuestionario de Salud SF-36 (SF-36) desde la visita basal y la de la semana 16 del estudio AMB115811, cada tres meses.
    - El cambio de la concentración del propéptido natriurético tipo B N-Terminal (pro-BNP-NT) desde la visita de la semana inicial a la de la semana 16 del estudio AMB115811 cada tres meses.
    Otros
    - El cambio de los datos de las valoraciones hemodinámicas cardiopulmonares desde la visita basal y la de la semana 16 del estudio AMB115811 en sujetos en los que se considera que los datos hemodinámicos forman parte de las normas asistenciales (Standard of Care).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly, every 3 months, every 6 months and follow-up visits
    Mensualmente, cada 3 meses, cada 6 meses y en las visitas de seguimiento.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA46
    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
    Austria
    Brazil
    Canada
    China
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Russian Federation
    Spain
    Sweden
    United Kingdom
    United States
    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
    LSLV
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 137
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 138
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 275
    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)
    Subjects can remain in this study until one of the following conditions is met:
    ? The product is approved locally and reimbursed for use in inoperable CTEPH patients;
    ? Development for use in the CTEPH population is discontinued or product is not approved locally;
    ? The investigator decides to discontinue the subject or subject decides to discontinue from the study.
    Please view section 5.7 of the protocol for further information.
    Los sujetos pueden permanecer en este estudio hasta que se cumpla una de las siguientes condiciones:
    - El producto se ha aprobado a nivel local y se reembolsa para su uso en pacientes con HPTEC no operable;
    - se suspende el desarrollo para su uso en la población con HPTEC o no se aprueba el producto a nivel local;
    - El investigador decide discontinuar al sujeto o el paciente decide retirarse del estudio.
    Por favor, refierase al Apartado 5.7 del Protocolo para más informaicón.
    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 Decision2013-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-18
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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