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    Summary
    EudraCT Number:2010-022969-95
    Sponsor's Protocol Code Number:AC-055C302
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-11-18
    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 number2010-022969-95
    A.3Full title of the trial
    Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis.
    Estudio prospectivo, aleatorizado, controlado con placebo, doble ciego, multicéntrico, de grupos paralelos para evaluar la eficacia, seguridad y tolerabilidad de macitentan en pacientes con úlceras digitales isquémicas asociadas a esclerosis sistémica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).
    Un ensayo clínico con macitentan que evalúa sus efectos en úlceras digitales asociadas a esclerosis sistémica (escleroderma).
    A.3.2Name or abbreviated title of the trial where available
    DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis.
    DUAL-2: Úlceras digitales con macitentan en esclerosis sistémica.
    A.4.1Sponsor's protocol code numberAC-055C302
    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_ch@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 No
    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 namemacitentan
    D.3.2Product code macitentan
    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 INNmacitentan
    D.3.9.1CAS number 441798-33-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemacitentan
    D.3.2Product code macitentan
    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 INNmacitentan
    D.3.9.1CAS number 441798-33-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischemic digital ulcers associated with systemic sclerosis
    Úlceras digitales isquémicas asociadas a esclerosis sistémica
    E.1.1.1Medical condition in easily understood language
    Difficult-to-heal open sores on fingers (Digital Ulcers) associated with a disease that leads to hardening of the skin, blood vessels and internal organs (Systemic sclerosis)
    Dificultad para cicatrizar úlceras abiertas en dedos (Úlceras Digitales) asociadas a enfermedad (Esclerosis Sistémica) que conduce a endurecimiento de la piel, vasos sanguíneos y a organos internos
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the effect of macitentan on the reduction of the cumulative number of new digital ulcers at Week 16 in patients with systemic sclerosis and and ongoing digital ulcer (DU) disease.
    Demostrar el efecto de macitentan sobre la reducción del número de nuevas úlceras digitales en la Semana 16 en pacientes con esclerosis sistémica y enfermedad de ulceras digitales (DU) en curso.
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of macitentan on hand functionality an dDU burden at Week 16 in systemic sclerosis (SSc) patients with ongoing DU disease.
    -To evaluate the safety and tolerability of macitentan in SSc patients with ongoing DU disease.
    -To evaluate the efficacy of macitentan on time to first DU complication during the entire treatment period.
    - Evaluar la eficacia de macitentan sobre la funcionalidad de la mano y la carga de UD en la Semana 16 en pacientes con esclerosis sistémica (SSc) con enfermedad de DUs en curso.
    - Evaluar la seguridad y tolerabilidad de macitentan en pacientes con SSc con UDs en curso.
    -Evaluar la eficacia de macitentan en el momento de primera complicación de UD durante el periodo completo de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR) [Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee 1980], or having ever met criteria for CREST syndrome (with sclerodactyly and 2 out of the 4 remaining criteria: calcinosis, Raynaud?s phenomenon, esophageal dysmotility, and telangiectasia).
    -At least one visible, active ischemic digital ulcer (DU) at baseline, located at or distal to the PIP joints or at the digital tip, and that developed or worsened within 8 weeks prior to screening
    -History of at least one additional active ischemic DU within 6 months, or at least two within 12 months prior to Screening (Visit 1).
    - Diagnóstico de SSC de acuerdo a los criterios de clasificación del Colegio Americano de Reumatología (ACR) [Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee 1980], o haber cumplido alguna vez criterios para el síndrome CREST (con
    esclerodactilia y 2 de los 4 criterios restantes: calcinosis, fenómeno de Raynaud, disfunción esofágica y telangiectasia.
    - Al menos una úlcera digital (DU) isquémica activa y visible en la visita basal, localizada en o distal a las articulaciones PIP o en el extremo digital, y que se desarrolló o empeoró dentro de las 8 semanas antes de la selección.
    - Historia de al menos una DU isquémica activa adicional dentro de 6 meses, o al menos dos dentro de 12 meses antes de la Selección (Visita 1)
    E.4Principal exclusion criteria
    1. DUs due to condition other than SSc.
    2. Symptomatic pulmonary arterial hypertension (PAH).
    3. Body mass index (BMI: kg/m2) < 18.
    4. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal (ULN).
    5. Hemoglobin < 75% of the lower limit of the normal range.
    6. Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg at Screening (Visit 1) and Randomization (Visit 2).
    7. Severe malabsorption, defined as greater than 15% unintentional loss of body weight in the last 6 months prior to randomization; any severe organ failure (e.g., lung, kidney), or any life-threatening condition.
    8. Comorbidities, other than SSc, that could seriously affect the assessment of hand function.
    9. Females who are pregnant or breastfeeding or plan to do so during the course of this study.
    10. Substance or alcohol abuse or dependence, within 12 months prior to Screening (Visit 1) or tobacco use at any level within the past 6 months prior to Screening (Visit 1).
    11. Treatment with PDE5 inhibitors (e.g., sildenafil, tadalafil).
    12. Patients on statins (e.g., atorvastatin, simvastatin), who have received treatment for less than 3 months prior to Screening (Visit 1) or whose treatment has not been stable during this period.
    13. Patients on vasodilators, such as calcium channel blockers, ACE-inhibitors, nitroglycerin, alpha adrenergic blockers, or angiotensin II receptor antagonists, N acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment for less than 2 weeks prior to Screening (Visit 1) or whose treatment has not been stable during this period.
    14.Treatment with prostanoids.
    15.Treatment with disease modifying agents such as methotrexate and cyclophosphamide if present for less than 3 months prior to Screening (Visit 1) or whose treatment has not been stable for at least 1 month prior to Screening (Visit 1).
    16. Treatment with oral corticosteroids (? 10 mg/day of prednisone or equivalent).
    17. Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to Screening (Visit 1).
    18. Systemic antibiotics (oral and IV) to treat infected DU(s) within 4 weeks prior to Screening (Visit 1).
    19. Use of topical growth factors, hyperbaric oxygen.
    20. Local injection of botulinum toxin in an affected finger within 4 weeks prior to Screening (Visit 1).
    21. Surgical sympathectomy of the upper limbs or surgical wound debridement within 1 month prior to Screening (Visit 1).
    22. Treatment with cytochrome P450 3A (CYP3A) inducers, such as rifabutin, rifampin, rifapentin, carbamazepine, phenobarbital, phenytoin, St. John?s wort, within 4 weeks prior to Screening (Visit 1).
    23. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
    24. Planned treatment, or treatment with another investigational drug within 4 weeks prior to Screening (Visit 1).
    25. Any condition that prevents compliance with the protocol or adherence to therapy, including inability to speak, read, or understand the local language well enough to complete all study assessments.
    1.DUs debidos a otros motivos distintos de SSc.
    2.Hipertensión arterial pulmonar sintomática (PAH).
    3.Índice de masa corporal (BMI: kg/m2) <18.
    4.Aspartato aminotransferasa (AST) y/o alanino aminotransferasa (ALT) sérica > 1.5 veces el límite superior del valor normal (ULN).
    5.Hemoglobina < 75% del límite inferior de los rangos normales.
    6.Presión arterial sistólica < 95 mmHg o presión arterial diastólica < 50 mmHg.
    7.Malabsorción grave, cualquier fallo orgánico grave (ej., pulmón, riñón), o cualquier condición de peligro para la vida.
    8.Comorbilidades, distintas al SSc, que pudiesen afectar seriamente la evaluación de la funcionalidad de la mano
    9.Mujeres que estén embarazadas o lactantes o tengan planeado realizarlo durante el curso de este estudio.
    10.Abuso o dependencia de sustancias o alcohol o tabaco.
    11.Tratamiento con inhibidores de la PDE5 (ej., sildenafilo, tadalafilo).
    12.Pacientes con estatinas (ej., atorvastatina, simvastatina), que hayan recibido tratamiento durante menos de 3 meses antes de la Selección (Visita 1) o cuyo tratamiento no haya sido estable durante este periodo.
    13.Pacientes con vasodilatadores, N-acetilcisteína, terapia de agregación antiplaquetaria y heparina de bajo peso molecular, que hayan recibido tratamiento durante menos de 2 semanas antes de la Selección (Visita 1) o cuyo tratamiento no haya sido estable durante este periodo.
    14.Tratamiento con prostanoides.
    15. Tratamiento con agentes modificadores de la enfermedad como methotrexato y ciclofosfamida si se administra al menos tres meses antes de la elección (Visita 1) o cuyo tratamiento no ha sido estable durante al menos 1 mes antes de la selección (Visita 1 )
    16. Tratamiento con corticoides orales(> 10 mg/día con prednisona o equivalente).
    17.Tratamiento con antagonistas de los receptores de la endotelina (ERAs).
    18.Antibióticos sistémicos (oral y i.v.) para tratar DU(s) infectadas.
    19.Utilización de factores de crecimiento tópicos, oxígeno hiperbárico.
    20.Inyección local de toxina botulínica en un dedo afectado dentro de las 4 semanas anteriores a la Selección.
    21. Simpactectomía quirúrgica de los miembros superiores o desbridamiento quirúrgico de la herida dentro de 1 mes antes de la Selección.
    22.Tratamiento con inductores del citocromo P450 3A (CYP3A4), como la rifabutina, rifampicina, rifapentina, carbamacepina, fenobarbital, fenitoína, hierba de San Juan, dentro de las 4 semanas anteriores a la Selección.
    23.Hipersensibilidad conocida a fármacos de la misma clase que el fármaco del estudio, o a alguno de sus excipientes.
    24.Tratamiento programado, o tratamiento con otro fármaco en investigación en las 4 semanas anteriores a la Selección.
    25. Cualquier otra situación que impida el cumplimiento con el protocolo del estudio o adherencia a la terapia, incluyendo la incapacidad para hablar, leer, o entender el idioma local suficientemente bien como para completar todas las evaluaciones del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint (assessed during Period 1)
    Cumulative number of new DUs up to Week 16.
    Objetivo principal (evaluado durante el Periodo 1)
    Número total de nuevas DUs hasta la Semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End-of-Period 1 (Week 16)
    Final-del-Periodo 1 (Semana 16)
    E.5.2Secondary end point(s)
    ? Hand Functionality:
    i. HDISS-DU
    ii. HAQ-DI
    ? DU Burden:
    i. Binary response of patients without a new DU
    ii. Binary response of patients with more than 1, 2, 3, etc., new DU(s)
    iii. Total number of DUs observed
    iv. Time to onset of each new DU (1st, 2nd, 3rd, 4th, etc., DU)
    ? DU Complications: An event of DU complications is defined as the composite of the following:
    i. Critical ischemic crisis necessitating patient hospitalization.
    ii. Gangrene, (auto)amputation.
    iii. Failure of conservative management: Surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand manifestation(s).
    iv. Use of parenteral prostanoids.
    v. Use of endothelin receptor antagonists.
    vi. Requiring class II, III or IV narcotics or increase in existing dose of ? 50% as compared to baseline.
    vii. Initiation of systemic antibiotics for the treatment of infection attributed to digital ulceration.
    ? Funcionalidad de la mano:
    i. HDISS-DU
    ii. HAQ-DI
    ? Carga de DU:
    i. Respuesta binaria de pacientes sin una nueva DU
    ii. Respuesta binaria de pacientes con más de 1, 2, 3, etc., nuevas DU(s)
    iii. Número total de DUs observadas
    iv. Tiempo hasta aparición de cada nueva DU (1a, 2da, 3ra, 4a, etc., DU)
    ? Complicaciones de DU: Un evento de complicaciones de DU se define como la composición de lo siguiente:
    i. Crisis isquémica crítica que requiere hospitalización.
    ii. Gangrena, (auto)amputación.
    iii. Fallo del manejo conservador: Simpatectomía quirúrgica y química, reconstrucciones vasculares, o cualquier cirugía no programada en el manejo de la(s) manifestación(es) de la mano.
    iv. Utilización de prostanoides parenterales.
    v. Uso de antagonistas del receptor de la endotelina.
    vi. Requerir narcóticos clase II, III o IV o incremento de la dosis existente de > 50% comparado con la situación basal.
    vii. Inicio de antibióticos sistémicos para el tratamiento de infecciones atribuidas a la ulceración digital.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Period 1: 4 visits (week 4, 8, 12 and 16)
    -Period 2: varialble number of visits every 3 months
    -Periodo 1: 4 visitas (semanas 4, 8, 12 and 16)
    -Periodo 2: número variable de visitas cada 3 meses
    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 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 trial3
    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 EEA34
    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
    Belgium
    Colombia
    Germany
    Greece
    Ireland
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Puerto Rico
    Russian Federation
    South Africa
    Spain
    Turkey
    Ukraine
    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
    Last patient Last Safety Follow up: 30 days after LPLV
    Último Paciente Último Seguimiento de Seguridad: 30 días después de LPLV.
    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 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: 242
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 295
    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)
    When the results of the AC-055C301 study become available, and a statistically significant favourable effect on ischemic DU with macitentan is demonstrated, an open-label study extension (under a separate protocol) may be offered to patients who complete the study as scheduled.
    Cuando los resultados de los estudios AC-055C301 estén disponibles y se demuestre un efecto favorable estadísticamente significativo sobre la DU isquémica tratada con macitentan, se podría ofrecer un estudio abierto (bajo un protocolo independiente) a los pacientes que completen el estudio según está programado.
    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 Decision2011-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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