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    Summary
    EudraCT Number:2018-002823-41
    Sponsor's Protocol Code Number:AC-065B302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-14
    Trial 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 number2018-002823-41
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallelgroup,group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an addon
    to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment ChronicThromboembolic Pulmonary Hypertension.
    Studio di Fase 3, adattativo, a gruppi paralleli e coorti sequenziali, controllato con placebo, in doppio cieco, randomizzato, multicentrico, con periodo di estensione in aperto, per valutare l’efficacia e la sicurezza di selexipag in aggiunta alla terapia con standard di cura, in soggetti con ipertensione polmonare cronica tromboembolica inoperabile o persistente/recidivante dopo trattamento chirurgico e/o interventistico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic
    Thromboembolic Pulmonary Hypertension (CTEPH).
    Studio clinico per valutare l'efficacia e la sicurezza di selexipag in aggiunta alla terapia con standard di cura in soggetti con ipertensione polmonare cronica tromboembolica inoperabile o persistente/recidivante dopo trattamento chirurgico e/o interventistico
    A.3.2Name or abbreviated title of the trial where available
    SELECT
    SELECT
    A.4.1Sponsor's protocol code numberAC-065B302
    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 pointClinical Trial Disclosure Desk
    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-mailclinical-trials-disclosure@its.jnj.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 Uptravi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSELEXIPAG
    D.3.2Product code [ACT-293987]
    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 INNSELEXIPAG
    D.3.9.2Current sponsor codeACT-293987
    D.3.9.4EV Substance CodeSUB130805
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
    Ipertensione polmonare cronica tromboembolica inoperabile o persistente/recidivante
    E.1.1.1Medical condition in easily understood language
    Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a disease associated with abnormally high pressure in the blood vessels of the lungs, caused by the formation of blood clots.
    L'ipertensione polmonare cronica tromboembolica è una malattia associata a una pressione anormalmente elevata nei vasi sanguigni dei polmoni, causata dalla formazione di coaguli di sangue.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 of the study is to evaluate the effect of selexipag on pulmonary vascular resistance (PVR) versus placebo in subjects with inoperable CTEPH (i.e., technically non-operable) and persistent/recurrent CTEPH after surgical (pulmonary endarterectomy [PEA]) and/or interventional (balloon pulmonary angioplasty [BPA]) treatment at Week 20.
    Valutare l’effetto di selexipag sulla resistenza vascolare polmonare (PVR) rispetto al placebo in soggetti con CTEPH inoperabile (cioè, tecnicamente non operabile) e CTEPH persistente/recidivante dopo trattamento chirurgico (endoarteriectomia polmonare [PEA]) e/o trattamento interventistico (angioplastica polmonare a palloncino [BPA]) alla Settimana 20.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the effects of
    selexipag versus placebo on:
    • Exercise capacity.
    • Time to clinical worsening (TTCW).
    • All-cause death or hospitalizations related to PH worsening.
    • WHO FC.
    • Patient-reported outcomes (PROs).
    • Dyspnea.
    • N-terminal pro b-type natriuretic peptide (NT-proBNP).
    Valutare gli effetti di selexipag rispetto al placebo su:
    • Capacità di esercizio fisico.
    • Tempo al peggioramento clinico
    • Tutte le cause di decesso od ospedalizzazioni correlate al peggioramento dell’ipertensione polmonare (PH).
    • Classe funzionale OMS (WHO-FC).
    • Esiti riferiti dal paziente.
    • Dispnea.
    • Pro-peptide natriuretico di tipo B N-terminale (NT-proBNP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated ICF.
    2. Male and female subjects >or=18 (or the legal age of consent in the jurisdiction in which the study is taking place) < or= 85 years old at Screening (Visit 1).
    3. Subjects with diagnosis of CTEPH and inoperability confirmed by the corresponding adjudication
    committee (AC; country-specific adjudication committee [CSAC] or central adjudication committee [CAC] (see Section 3.4.3), defined as one of the following options:
    a) Inoperable CTEPH (ie., technically non-operable) with:
    – Diagnosis of CTEPH based on at least two of the following assessments
    performed in the 14-month period prior to randomization (Visit 2):
    ventilation/perfusion (V/Q) scan; pulmonary angiography (PA);
    computed tomography pulmonary angiogram (CTPA) and/or magnetic
    resonance angiography (MRA).
    – RHC (and LHC, if needed) 1 performed at least 90 days after start of full anticoagulation, showing:
    o PVR at rest >or=400 dyn.sec/cm5 or =5 Wood units for the hemodynamic cohort and PVR at rest >or=300 dyn.sec/cm5 or >or=3.75 Wood units for the
    non-hemodynamic cohort,
    o Mean pulmonary arterial pressure (mPAP) >or=25 mmHg;
    Pulmonary arterial wedge pressure (PAWP) = 15 mmHg or, if not available or unreliable, a left ventricular end diastolic pressure (LVEDP) = 15 mmHg.
    b) Persistent/recurrent CTEPH after BPA and deemed inoperable with:
    – Diagnosis of CTEPH based on at least one of the following assessments performed in the 14-month period prior to randomization (Visit 2) and after last interventional (BPA) treatment: V/Q scan, PA, CTPA or MRA.
    – RHC (and LHC, if needed)1 performed at least 90 days after last interventional (BPA) treatment and at least 90 days after start of full anticoagulation, showing: PVR at rest >or =400 dyn.sec/cm5 or >oe =5 Wood units for the hemodynamic cohort and PVR at rest >or=300 dyn.sec/cm5 or >or=3.75 Wood units for the non-hemodynamic cohort, mPAP >or= 25 mmHg; PAWP <or= 15 mmHg, or, if not available or unreliable, an LVEDP =
    15 mmHg.
    c) Persistent/recurrent CTEPH after PEA (including PEA followed by BPA) with: – Diagnosis of CTEPH based on at least one of the following assessments performed in the 14-month period prior to randomization (Visit 2) and after last surgical (PEA) or interventional (BPA) treatment: V/Q scan,PA, CTPA or MRA.
    -RHC(and LHC, if needed)1 performed at least 90 days after last surgical (PEA) or interventional (BPA) treatment and at least 90 days after start of full anticoagulation, showing: PVR at rest >or= 400 dyn.sec/cm5 or 5 Wood units for the hemodynamic cohort and PVR at rest =300 dyn.sec/cm5 or =3.75 Wood units for the non-hemodynamic cohort,
    o mPAP >or=25 mmHg,
    o PAWP <or=15 mmHg, or, if not available or unreliable, an LVEDP <or=15 mmHg.
    4. PH in WHO FC I–IV.
    5. Subject able to perform the 6MWT with a minimum distance of 100 m and a maximum distance of 450 m at screening visit (Visit 1).
    6. A woman of childbearing potential [see definition in Section 4.5.1] is eligible only if all the following applies:
    a. Negative serum pregnancy test at Screening and a negative urine pregnancy test at randomization.
    b. Agreement to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation.
    c. Agreement to use one of the methods of birth control described in Section 4.5 from Screening visit up to at least 30 days after study treatment discontinuation.
    1. Modulo di consenso informato firmato e datato.
    2. Soggetti di sesso maschile e femminile di età >o=18 (o che abbiano raggiunto la maggiore età, considerata tale, nei Paesi in cui si svolge lo studio) e <=85 anni anni allo screening (Visit1).
    3. Soggetti con diagnosi di CTEPH, e inoperabilità confermate dal corrispondente comitato di revisione (AC; Comitato di revisione specifico per paese [CSAC] o dal Comitato di revisione centrale [CAC]) [vedere Sezione 3.4.3], definita come una delle seguenti opzioni:
    a. CTEPH inoperabile (cioè, tecnicamente non operabile) con:
    -Diagnosi di CTEPH basata su almeno due delle seguenti valutazioni eseguite nel periodo di 14 mesi precedente la randomizzazione (Visita 2):
    oScintigrafia ventilatoria/perfusoria (scansione V/Q).
    o Angiografia polmonare (PA), angiogramma polmonare con tomografia computerizzata (CTPA) e/o
    o Angiografia con risonanza magnetica (MRA).
    -RHC(e LHC, se necessario) 1 eseguito almeno 90 giorni dopo l’inizio della terapia anticoagulante completa, che evidenzia:
    o PVR a riposo >o=400 dyn.s/cm5 o >o=5 Wood units per la coorte emodinamica e PVR a riposo >o=300 dyn.sec/cm5 o >o=3.75 Wood units per la coorte non-emodinamica..
    o Pressione arteriosa polmonare media mPAP >o=25 mmHg.
    o Pressione di incuneamento dell’arteria polmonare (PAWP) <o=15 mmHg o, se il valore non è disponibile o non affidabile, pressione telediastolica ventricolare sinistra (LVEDP) <o=15 mmHg.
    b. CTEPH persistente/recidivante dopo BPA, e diventato inoperabile con:
    -Diagnosi di CTEPH basata su almeno una delle seguenti valutazioni effettuate nel periodo di 14 mesi precedente la randomizzazione (Visita 2) e dopo l'ultimo trattamento interventistico (BPA): Scintigrafia ventilatoria/perfusoria (scansione V/Q), PA, CTPA o MRA.
    -RHC1 (e LHC, se necessario)eseguito almeno 90 giorni dopo dopo l'ultimo trattamento interventistico (BPA): e almeno 90 giorni dopo l’inizio della terapia anticoagulante completa, che evidenzia:
    o PVR a riposo >0=400 dyn.s/cm5 o >0= 5 Wood units per la coorte emodinamica e PVR a riposo >o=300 dyn.sec/cm5 o >o=3.75 Wood unitàs per la coorte non-emodinamica
    o mPAP >o=25 mmHg.
    o PAWP <o=15 mmHg o, se non disponibile o non affidabile, LVEDP <o=15 mmHg.
    c. CTEPH persistente/recidivante dopo PEA (inclusa PEA seguita da BPA) con:
    -Diagnosi di CTEPH basata su almeno una delle seguenti valutazioni eseguite nel periodo di 14 mesi prima della randomizzazione (Visita 2) e dopo l'ultimo trattamento chirurgico (PEA) o interventistico (BPA): scansione V/Q, PA, CTPA o MRA.
    -RHC(e LHC, se necessario)1 eseguito almeno 90 giorni dopo l'ultimo trattamento chirurgico (PEA) o interventistico (BPA) e almeno 90 giorni dopo l’inizio della terapia anticoagulante completa, che evidenzia:
    o PVR a riposo >0=400 dyn.s/cm5 o >0= 5 Wood units per la coorte emodinamica e PVR a riposo >o=300 dyn.sec/cm5 o >o=3.75 Wood units per la coorte non-emodinamica
    o mPAP >o=25 mmHg.
    o PAWP <o=15 mmHg o, se non disponibile o non affidabile, LVEDP =15 mmHg.
    4. PH in FC OMS I-IV.
    5. Soggetto capace di eseguire il 6MWT per una distanza minima di 100 m e una distanza massima di 450 m alla visita di screening (Visita 1).
    E.4Principal exclusion criteria
    General exclusion criteria:
    1. Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
    2. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
    3. Known concomitant life-threatening disease with a life expectancy < 12 months.
    Exclusion criteria related to the disease:
    4. Planned BPA within 26 weeks after randomization.
    5. Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort.
    6. Treatment with prostacyclin (epoprostenol), prostacyclin analogs (ie, treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (ie, selexipag/Uptravi®) within 90 days prior to randomization (Visit 2), except those given at vasodilator testing during RHC.
    7. Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed).
    Exclusion criteria related to comorbidities:
    8. Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc).
    9. Other as per selexipag Summary of Product Characteristics (SmPC).
    Exclusion criteria related to selexipag use:
    10. As per selexipag Summary of Product Characteristics (SmPC).
    Criteri di esclusione generali
    1. Trattamento pianificato o in atto con un’altra terapia sperimentale fino a 3 mesi prima della randomizzazione.
    2. Qualsiasi fattore o disturbo noto che potrebbe interferire con la compliance al trattamento, la conduzione dello studio o l’interpretazione dei risultati, come ad esempio la dipendenza da droghe o alcol o una malattia psichiatrica.
    3. Concomitanza nota di malattia potenzialmente letale con un’aspettativa di vita <12 mesi.
    Criteri di esclusione legati alla malattia
    4. BPA pianificata entro 26 settimane dalla randomizzazione.
    5. Modifica della dose o inizio di una nuova terapia specifica per la PH entro 90 giorni dall’ RHC eseguita alla visita di baseline (e LHC, se necessario) per l’arruolamento nella corte emodinamica ed entro i 90 giorni prima della randomizzazione (Visit 2) per la corte non-emodinamica .
    6. Trattamento con prostaciclina (epoprostenolo), analoghi della prostaciclina (ad es. treprostinil, iloprost, beraprost) o agonisti del recettore della prostaciclina (cioè selexipag/Uptravi) entro 90 giorni dalla randomizzazione (Visita 2) eccetto per quelli somministrati nel test vasodilatazione durante l’RHC.
    7. Modifica della dose o inizio di una nuova terapia con diuretici e/o bloccanti i canali del calcio entro 1 settimana prima della RHC basale (e LHC, se necessario).
    Criteri di esclusione relativi alle comorbilità
    8. Qualsiasi malattia concomitante che può influire sulla capacità di eseguire un test 6MWT affidabile e riproducibile, compreso l’utilizzo di ausili per camminare (bastone, deambulatore e così via).
    9. Altro come da SmPC del Selexipag
    Criteri di esclusione relativi all’uso di selexipag
    10. Come da SmPC del Selexipag
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the pulmonary vascular
    resistance (PVR) at Week 20, assessed at rest, within 2–5 hours postdose,
    expressed as percent of baseline PVR.
    L'endpoint primario di efficacia di questo studio è la resistenza vascolare polmonare
    (PVR) alla settimana 20, valutata a riposo, entro 2-5 ore dopo la dose,
    espressa come percentuale del PVR basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed at rest in screening period (Day -60 to Day -14; baseline) and
    assessed at rest within 2–5 hours post-dose at Week 20 during
    treatment period.
    Valutata a riposo nel periodo di screening (dal giorno -60 al giorno -14, basale) e
    valutata a riposo entro 2-5 ore dopo la dose alla settimana 20 durante il
    periodo di trattamento.
    E.5.2Secondary end point(s)
    1. Change from baseline in 6-minute walk distance (6MWD) to Week 26 (key secondary endpoint).
    2. TTCW (key secondary endpoint), where clinical worsening is defined (adapted from the CHMP definition [EMEA 2008]) as at least one of the following components confirmed by the CEC, when applicable:
    – All-cause death
    – Non-planned PH-related hospitalization
    – PH-related deterioration identified by at least one of the following:
    • Increase from baseline in WHO FC4;
    • Deterioration from baseline by at least 15% in exercise capacity, as measured by the 6MWD4;
    New or worsening signs or symptoms of right heart failure,
    defined as a reported AE with one of the preferred terms "CTEPH", "pulmonary hypertension", "right ventricular failure", "right ventricular dysfunction" and/or "acute right ventricular failure".
    3. All-cause death or hospitalizations related to PH worsening.
    4. Improvement in WHO FC from baseline
    4. Proportion of subjects with improvement in WHO FC from baseline to Week 26.
    5. Change from baseline to Week 26 in Pulmonary arterial hypertensionsymptoms
    and impact questionnaire (PAH-SYMPACT®) cardiopulmonary symptoms domain and cardiovascular symptoms domain.
    6. Change from baseline to Week 26 in Borg dyspnea index (BDI)/Borg
    CR10®.
    7. Change from baseline to Week 26 in NT-proBNP.
    1. Modifica dal basale nel 6MWD alla Settimana 26 (endpoint secondario chiave).
    2.Tempo al peggioramento clinico (endpoint secondario chiave) dove il peggioramente clinico è definito (adattato dal Committee for Medicinal Products for Human Use (CHMP)] come almeno uno dei seguenti elementi, confermati dal CEC, quando applicabile:
    ¿ Decesso per qualsiasi causa.
    ¿ Ospedalizzazione non programmata correlata alla PH.
    ¿ Peggioramento correlato alla PH identificato mediante almeno uno dei seguenti:
    o Aumento, rispetto al basale, della classe funzionale OMS (WHO-FC);
    o Peggioramento, rispetto al basale, di almeno il 15% della capacità di esercizio fisico, misurato attraverso il 6MWD4;
    Nuovo o peggioramento dei segni o sintomi di insufficienza cardiaca destra definiti come AE segnalati con uno dei seguenti termini preferiti: «CTEPH», «ipertensione polmonare», «insufficienza ventricolare destra», «disfunzione ventricolare destra» e «insufficienza ventricolare destra acuta».
    3.Tutte le cause di morte o ospedalizzazione correlate al peggioramento della PH.
    •4.Aumento della FC OMS dal basale alla Settimana 26.
    •5. Variazione dal basale alla Settimana 26 dei punteggi del questionario sui sintomi e impatto dell'ipertensione polmonare arteriosa (PAH-SYMPACT™®), nell’ambito dei sintomi cardio polmonari e cardio vascolari.
    6.Variazione dal basale alla Settimana 26 nell’indice di dispnea di Borg / Borg CR10®.
    7.Variazione dal basale alla Settimana 26 nell’NTproBNP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 26
    2. end of double blind treatment period
    3. end of double blind treatment period
    4. Week 26
    5. Week 26
    6. Week 26
    7. Week 26
    1. Settimana 26
    2. alla fine del periodo in doppio cieco
    3. alla fine del periodo in doppio cieco
    4. Settimana 26
    5.Settimana 26
    6. Settimana 26
    7. Settimana 26
    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 Yes
    E.8.1.7.1Other trial design description
    gruppo sequenziale
    group sequential
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 Information not present in EudraCT
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Czechia
    Denmark
    Estonia
    Finland
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Democratic People's Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Portugal
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months5
    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: 182
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 98
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 280
    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)
    After the subject's study completion, the investigator/delegate will
    explain to subjects what treatment(s) / medical care is necessary and
    available according to local regulations. If indicated, the Sponsor will
    provide subjects who completed the study and did not prematurely
    discontinue study treatment with OL study treatment until access to commercial
    selexipag is possible in this indication in the subject's country of
    residence, according to local regulatory requirements.
    Dopo il completamento dello studio del soggetto, lo sperimentatore / delegato spiegherà ai soggetti quale trattamento / cura medica sono necessari e disponibili secondo le normative locali. Se indicato, Actelion fornirà ai soggetti, che hanno completato lo studio e che non hanno sopseso prematuramente il trattamento di studio, il trattamento in aperto (OL) fino alla commercializzazione, per l'indicazione in studio, nel paese di residenza del soggetto, in linea con i requisiti normativi locali.
    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 Decision2019-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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