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    Summary
    EudraCT Number:2010-022710-77
    Sponsor's Protocol Code Number:AC-055C301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022710-77
    A.3Full title of the trial
    Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis.
    Studio prospettico, randomizzato, controllato con placebo, in doppio cieco, multicentrico, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilita' del macitentan in pazienti affetti da ulcere digitali ischemiche associate a sclerosi sistemica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)
    Studio di ricerca clinica con macitentan per valutare i suoi effetti sulle ulcere digitali associate a sclerosi sistemica (sclerodermia).
    A.3.2Name or abbreviated title of the trial where available
    DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis)
    DUAL-1
    A.4.1Sponsor's protocol code numberAC-055C301
    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.5.4Telephone number.
    B.5.5Fax number.
    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 ACT-064992
    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.3.9.2Current sponsor codeACT-064992
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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 ACT-064992
    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.3.9.2Current sponsor codeACT-064992
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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
    Ulcere digitali ischemiche associate a sclerosi sistemica
    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'')
    Piaghe aperte difficili da curare sulle dita (ulcere digitali) associate a una patologia che porta ad un indurimento della pelle, dei vasi sanguigni e degli organi interni (sclerodermia)
    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 14.1
    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 ongoing digital ulcer (DU) disease.
    Dimostrare l'effetto del macitentan nella riduzione del numero di nuove ulcere digitali alla Settimana 16, in pazienti affetti da sclerosi sistemica ed ulcere digitali in corso.
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of macitentan on hand functionality and DU 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.
    •Valutare l'efficacia del macitentan sulla funzionalità della mano e sul burden delle ulcere digitali alla Settimana 16 in pazienti affetti da sclerosi sistemica (SSc) con ulcere digitali in corso. •Valutare la sicurezza e tollerabilità del macitentan in pazienti SSc con ulcere digitali in corso. •Valutare l'efficacia di macitentan sul periodo necessario per l’insorgenza della prima complicazione dell’ulcera digitale (UD) durante l'intero periodo di trattamento.
    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), or having ever met criteria for CREST syndrome (with sclerodactyly and 2 out of the 4 remaining criteria: calcinosis, Raynaud's phenomenon, esophageal dysfunction, telangiectasia). - At least one visible, active ischemic DU at baseline, located at or distal to the proximal interphalangeal joints (PIP) 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.
    •Diagnosi di SSc secondo i criteri di classificazione dell'American College of Rheumatology (ACR) o l’aver soddisfatto, in qualsiasi momento, i criteri per la sindrome di CREST (con sclerodattilia e 2 dei 4 rimanenti criteri: calcinosi, fenomeno di Raynaud, disfunzione esofagea, teleangiectasia). •Almeno una UD ischemica attiva e visibile alla baseline, localizzata sulle articolazioni prossimali interfalangee (PIP) o in posizione distale, o sulla punta delle dita e che si sia sviluppata, o che sia peggiorata, nelle 8 settimane antecedenti lo screening (che soddisfi le specifiche definite dal protocollo per ulcera digitale attiva). •Storia di almeno un’ulteriore UD ischemica attiva nei 6 mesi, o di almeno due nei 12 mesi precedenti lo Screening (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 . 7. Severe malabsorption, 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, or tobacco use . 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, 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). 18. Systemic antibiotics (oral and i.v.) to treat infected DU(s) . 19. Use of topical growth factors, hyperbaric oxygen. 20. Local injection of botulinum toxin in an affected finger within 4 weeks prior to Screening. 21. Surgical sympathectomy of the upper limbs or surgical wound debridement within 1 month prior to Screening. 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. 23. Known hypersensitivity to drugs of the same class as the study drug, or any of the excipients. 24. Planned treatment, or treatment with another investigational drug within 4 weeks prior to Screening. 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.Ulcere digitali dovute a condizioni diverse dalla SSc. 2.Ipertensione arteriosa polmonare sintomatica (PAH). 3.Indice di massa corporea (BMI: kg/m2) &lt;18. 4.Aspartato aminotransferasi (AST) e/o alanina aminotransferasi (ALT) sieriche &gt; 1.5 volte il limite superiore dei valori normali (ULN). 5.Emoglobina &lt; 75% il limite inferiore dei valori normali. 6.Pressione arteriosa sistolica &lt; 95 mmHg o pressione arteriosa diastolica &lt; 50 mmHg. 7.Malassorbimento grave, insufficienza di qualsiasi organo (per es. polmoni, reni) o qualsiasi patologia che metta a repentaglio la vita. 8.Comorbilità, oltre alla SSc, che potrebbero seriamente incidere sulla valutazione della funzionalità della mano. 9.Donne incinte o in allattamento o che prevedano di diventarlo durante il corso di questo studio. 10.Abuso o dipendenza da sostanze o alcool o uso di tabacco. 11.Trattamento con inibitori della PDE5 (per es., sildenafil, tadalafil). 12.Pazienti in trattamento con statine (per es., atorvastatina, simvastatina), che abbiano ricevuto il trattamento per meno di 3 mesi prima dello Screening (Visita 1) o per i quali il trattamento non sia stato stabile durante questo periodo. 13.Pazienti in trattamento con vasodilatatori, N-acetilcisteina, anti-aggreganti piastrinici ed eparina a basso peso molecolare che abbiano ricevuto il trattamento per meno di 2 settimane prima dello Screening (Visita 1) o il cui trattamento non sia stato stabile durante questo periodo. 14.Trattamento con prostanoidi. 15.Trattamento con agenti modificanti la malattia (disease modifying) quali metotrexato e ciclofosfamide, se presenti per meno di 3 mesi prima dello Screening (Visita 1) o trattamenti che siano rimasti stabili per almeno 1 mese prima dello screening (Visita 1). 16.Trattamento con corticosteroidi orali (&gt; 10 mg/giorno di prednisone o equivalente). 17.Trattamento con antagonisti del recettore dell'endotelina (ERA). 18.Antibiotici sistemici (orali o per via endovenosa) per il trattamento di ulcere digitali infette. 19.Uso di fattori di crescita topici, ossigeno iperbarico. 20.Iniezioni locali di tossina botulinica in un dito interessato nelle 4 settimane precedenti lo Screening (Visita 1). 21.Simpaticectomia chirurgica degli arti superiori o debridement chirurgico della ferita nel mese precedente lo Screening (Visita 1). 22.Trattamento con induttori del citocromo P450 3A (CYP3A) quali rifabutina, rifampicina, rifapentina, carbamazepina, fenobarbitale, fenitoina, erba di San Giovanni, nelle 4 settimane precedenti lo Screening (Visita 1). 23.Ipersensibilità conosciuta ai farmaci della stessa classe del farmaco in studio, o ad uno qualsiasi degli eccipienti. 24.Trattamento, programmato o in atto, con un altro farmaco sperimentale nelle 4 settimane precedenti lo Screening (Visita 1). 25.Qualsiasi condizione che impedisca il rispetto del protocollo o l'aderenza alla terapia, compresa l'inabilità a parlare, leggere, o comprendere la lingua locale in maniera sufficiente da poter completare tutte le valutazioni dello studio.
    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.
    Endpoint primario (valutato durante il Periodo 1): Numero cumulativo di nuove ulcere digitali fino alla Settimana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End-of-Period 1 (Week 16)
    Fine del Periodo 1 (Settimana 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.
    •Funzionalità della mano: i. HDISS-DU ii. HAQ-DI •Burden della UD i.Risposta binaria di pazienti senza una nuova UD. ii.Risposta binaria di pazienti con più di 1, 2, 3, ecc. nuove ulcere digitali. iii.Numero totale delle ulcere digitali osservate. iv.Periodo necessario per l’insorgenza di ogni nuova UD (tempo alla 1°, 2°, 3° 4°, ecc., UD). •Complicazioni della UD: un evento di complicazione dell’ UD è definito come l’insieme composito dei seguenti criteri: i.Crisi ischemica critica richiedente il ricovero del paziente. ii.Cancrena, (auto) amputazione. iii.Fallimento della gestione conservativa: simpaticectomia chirurgica e chimica, ricostruzioni vascolari o qualsiasi intervento chirurgico non programmato nella gestione delle manifestazioni della mano. iv.Uso di prostanoidi per via parenterale. v.Uso di antagonisti del recettore dell’endotelina. vi.Necessità di narcotici della classe II, III o IV o incremento della dose già esistente di oltre il 50% rispetto al basale. vii.Inizio di trattamenti antibiotici sistemici per il trattamento di infezioni attribuite all’ulcera digitale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Period 1: 4 visits (week 4, 8, 12 and 16) - Period 2: variable number of visits every 3 month
    - Periodo 1: 4 visite (Settimana 4, 8, 12 e 16) - Periodo 2: numero variabile di visite trimestrali
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Belarus
    Canada
    Chile
    Colombia
    Croatia
    European Union
    India
    Russian Federation
    Ukraine
    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
    Ultimo controllo di sicurezza dell'ultimo paziente: 30 giorni dopo l'ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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.1.1Number of subjects for this age range: 0
    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: 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 285
    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 and AC-055C302 studies become
    available and a statistically significant favorable effect on ischemic DU with macitentan is demonstrated, an open-label study (under a separate protocol) may be offered to patients who complete the study as scheduled.
    Quando i risultati dello studio AC-055C301 saranno disponibili e sarà dimostrato un effetto favorevole statisticamente significativo del macitentan sulla UD ischemica, potrà essere offerto uno studio in aperto (con un protocollo separato) ai pazienti che abbiano completato lo studio come programmato.
    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 Decision2012-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-29
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