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Uno studio sul macitentan nei partecipanti pediatrici giapponesi con ipertensione arteriosa polmonare

16 aprile 2026 aggiornato da: Janssen Pharmaceutical K.K.

Uno studio multicentrico, in aperto, di fase III per valutare l'efficacia, la sicurezza e la farmacocinetica del macitentan in pazienti pediatrici giapponesi (da >=3 mesi a

Lo scopo di questo studio è valutare l'effetto del macitentan sulle misure emodinamiche alla settimana 24 nelle popolazioni pediatriche.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

7

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Giappone
      • Azumino-shi, Giappone, 399-8288
        • Nagano Children's Hospital
      • Bunkyō City, Giappone, 113 8519
        • Institute of Science Tokyo Hospital
      • Fukuoka, Giappone, 813-0017
        • Fukuoka Children's Hospital
      • Okayama, Giappone, 700 8558
        • Okayama University Hospital
      • Sapporo, Giappone, 060-8648
        • Hokkaido University Hospital
      • Setagaya Ku, Giappone, 157 8535
        • National Center for Child Health and Development
      • Shinjuku-ku, Giappone, 162-8666
        • Tokyo Women's Medical University Hospital
      • Suita-Shi, Giappone, 564-8565
        • National Cerebral and Cardiovascular Center
      • Suita-shi, Giappone, 565-0871
        • Osaka University Hospital
      • Tokyo, Giappone, 113-8655
        • The University of Tokyo Hospital
      • Ōta-ku, Giappone, 143-8541
        • Toho University Medical Center Omori Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 mesi a 15 anni (Bambino)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Ipertensione arteriosa polmonare (PAH) appartenente al gruppo 1 della classificazione aggiornata al Nice 2013
  • Diagnosi di PAH confermata dal cateterismo cardiaco destro storico in cui, in assenza di ostruzione della vena polmonare e/o malattia polmonare significativa, la pressione di incuneamento dell'arteria polmonare (PAWP) può essere sostituita dalla pressione dell'atrio sinistro (LAP) o dalla pressione telediastolica del ventricolo sinistro (LVEDP) (in assenza di stenosi mitralica) valutata mediante cateterismo cardiaco
  • Classe funzionale (FC) dell'Organizzazione Mondiale della Sanità (OMS) da I a IV
  • Partecipanti naïve al trattamento specifico per la PAH o partecipanti al trattamento specifico per la PAH
  • Una donna in età fertile deve avere un test sierico altamente sensibile della beta-gonadotropina corionica umana (beta-hCG) negativo allo screening e un test di gravidanza sulle urine negativo alla prima somministrazione dell'intervento dello studio
  • Una partecipante di sesso femminile non deve rimanere incinta e deve accettare di non donare ovuli durante lo studio e per un periodo fino a 4 settimane dopo la fine dello studio

Criteri di esclusione:

  • Partecipanti con PAH dovuta a ipertensione portale, schistosomiasi, malattia veno-occlusiva polmonare e/o emangiomatosi capillare polmonare e ipertensione polmonare persistente del neonato
  • Partecipanti con le seguenti malattie: stenosi della vena polmonare; displasia broncopolmonare
  • Compromissione epatica grave, ad esempio, classe Child-Pugh C, allo screening
  • Gravidanza, allattamento o pianificazione di una gravidanza durante l'arruolamento in questo studio o entro 4 settimane dall'ultima dose dell'intervento dello studio
  • Allergie note, ipersensibilità o intolleranza al macitentan o ai suoi eccipienti
  • Partecipante con PAH associata a shunt aperti, con anomalie cardiache congenite come cuore univentricolare, con ipertensione polmonare dovuta a malattia polmonare e disfunzione renale

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Macitentan
I partecipanti riceveranno una dose orale di macitentan in base all'età e al peso fino alla settimana 52.
Droga: Macitentan
Macitentan verrà somministrato per via orale sotto forma di compresse.
Altri nomi:
  • OPSUMIT
  • ZEPENDO

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ripiegare la variazione rispetto al basale alla settimana 24 dell'indice di resistenza vascolare polmonare (PVRI)
Lasso di tempo: Riferimento (giorno 1), settimana 24
La variazione del PVRI alla settimana 24 è stata calcolata come 100*(PVRI alla settimana 24 diviso per il PVRI al basale). La PVR è stata determinata mediante cateterizzazione del cuore destro.
Riferimento (giorno 1), settimana 24
Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
Lasso di tempo: Baseline (Day 1), Weeks 8, 16, 20, 40, 52
Change from baseline in hematology parameters: NBF was reported. Data for each parameters was planned to be reported at specified timepoints only.
Baseline (Day 1), Weeks 8, 16, 20, 40, 52

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
Lasso di tempo: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: PVR was reported. PVR is calculated as: PVR= (Mean pulmonary artery pressure [mPAP]-Pulmonary artery wedge pressure [PAWP)/ Cardiac output [CO].
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Mean Right Atrial Pressure (mRAP)
Lasso di tempo: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: mRAP was reported.
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Mean Pulmonary Arterial Pressure (mPAP)
Lasso di tempo: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: mPAP was reported. mPAP is calculated as: 2*diastolic pulmonary arterial pressure (dPAP) + systolic pulmonary arterial pressure (sPAP)/3.
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Index (CI)
Lasso di tempo: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: CI was reported. CI was calculated as: CO/Body surface area (BSA).
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Output (CO)
Lasso di tempo: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: CO was reported.
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Total Pulmonary Resistance (TPR)
Lasso di tempo: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: TPR was reported. TPR was calculated as: (mPAP/CO)*80.
Baseline (Day 1), Week 24
Percent Change From Baseline to Week 24 in Hemodynamic Variable: Mixed Venous Oxygen Saturation (SvO[2])
Lasso di tempo: Baseline (Day 1), Week 24
Percent change from baseline to Week 24 in hemodynamic variable: SvO(2) was reported.
Baseline (Day 1), Week 24
Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in World Health Organization (WHO) Functional Class (FC)
Lasso di tempo: Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
WHO-FC for participants with pulmonary arterial hypertension (PAH) ranges: Class I (no limitation in physical activity, ordinary physical activity did not cause undue dyspnea or fatigue, chest pain or near syncope), Class II (slight limitation of physical activity, comfortable at rest, ordinary physical activity caused undue dyspnea or fatigue, chest pain, or near syncope), Class III (marked limitation of physical activity, comfortable at rest, less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope) and Class IV (cannot perform a physical activity without any symptoms, signs of right heart failure, dyspnea and/or fatigue may be present even at rest, discomfort is increased by any physical activity). Participants who improve in WHO FC are reported below. Improvement was defined as reduction in FC.
Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama Functional Class (FC)
Lasso di tempo: Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Panama FC for PAH ranges: Class I (asymptomatic, growing normally, attending nursery/school regularly, no limitation of physical activity, playing sports with his/her classmates), Class II (slight limitation of physical activity, unduly dyspnoeic and fatigued when playing with his/her classmates, comfortable at rest, grow along own centiles, nursery/school attendance 75% normal, no chest pain), Class IIIa (marked limitation of physical activity, no attempt at sports, comfortable at rest, less than ordinary activity (example: dressing) causes undue dyspnea, fatigue, syncope and/or presyncope or chest pain, nursery/schooling compromised <50% normal attendance), Class IIIb (growth compromised, poor appetite, supplemental feeding, same as class IIIa) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in Panama FC are reported below. Improvement was defined as reduction in Panama FC.
Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline to Weeks 24 and 52 in 6-minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT)
Lasso di tempo: Baseline (Day 1), Weeks 24 and 52
Change from baseline to Weeks 24 and 52 in 6MWD as measured by 6MWT was reported. 6MWD was the distance that a participant could walk in 6 minutes. Rest periods were allowed if the participant could no longer continue. If the participant need to rest, he/she may pause, lean against the wall and continue walking whenever he/she feels able. The timer continued to run even if the participant stopped to rest.
Baseline (Day 1), Weeks 24 and 52
Change From Baseline to Weeks 12, 24, 28, 40, and 52 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Lasso di tempo: Baseline (Day 1), Week 12, 24, 28, 40, and 52
Change from baseline to Weeks 12, 24, 28, 40, and 52 in NT-proBNP was reported.
Baseline (Day 1), Week 12, 24, 28, 40, and 52
Change From Baseline to Weeks 12, 24, and 52 in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in TAPSE was reported. It was calculated as: original TAPSE value/body surface area (BSA). TAPSE was a dimension used to evaluate Right Ventricle (RV) longitudinal systolic function; it measured the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Week 12, 24, and 52 in Left Ventricular Eccentricity Index (LVEI)
Lasso di tempo: Baseline (Day 1), Weeks 12, 24 and 52
Change from baseline to Weeks 12, 24, and 52 in LVEI was reported. It included diastolic (D) LVEI and systolic (S) LVEI. Left ventricular (LV) internal diameters were measured using the parasternal short axis view at the level of the papillary muscles: D1: LV internal diameter perpendicular to interventricular septum at end-diastole; D2: LV internal diameter parallel to interventricular septum, and at right angle from D1, at end-diastole; S1: LV internal diameter perpendicular to interventricular septum at end-systole; S2: LV internal diameter parallel to interventricular septum, and at a right angle from S1, at end-systole. The LVEI was a ratio that was calculated by sponsor as: LVEI diastole = D2/D1; LVEI systole = S2/S1.
Baseline (Day 1), Weeks 12, 24 and 52
Change From Baseline to Week 12, 24, and 52 in Quality of Life (QoL) as Assessed by Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales Short Form (SF-15)
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in QoL as assessed by PedsQL 4.0 generic core scales SF-15 was reported. The PedsQL 4.0 questionnaire generic core scales score SF-15 assessed general physical, emotional, social and school functioning on a 5-point Likert scale from 0 to 4 with 0= if it is never a problem, 1= if it is almost never a problem, 2= if it is sometime a problem, 3= if it is often a problem, 4 if it is almost always a problem. Scores were transformed on a scale from 0 to 100. Higher scores indicated better health related QoL. The QoL questionnaire was completed by parent(s)/caregiver(s) and by participants.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Number of Hours of Daytime Activity
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: number of hours of daytime activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Count Per Minute of Daily Activity
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean count per minute of daily activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Light Physical Activity
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean daily time spent in light physical activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Moderate to Vigorous Physical Activity
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean daily time spent in moderate to vigorous physical activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Week 24 and Week 52 in Borg Dyspnea Index (BDI)
Lasso di tempo: Baseline (Day 1), Weeks 24 and 52
Change from baseline to Weeks 24 and 52 in BDI was reported. BDI was a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores ranged from 0 (no shortness of breath) to 10 (worst shortness of breath you have ever had). Higher score indicated worse outcome.
Baseline (Day 1), Weeks 24 and 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Lasso di tempo: From Baseline (Day 1) up to Week 56
Number of participants with TEAEs was reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days.
From Baseline (Day 1) up to Week 56
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Lasso di tempo: From Baseline (Day 1) up to Week 56
Number of participants with TESAEs was reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TESAEs are defined as any SAE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days.
From Baseline (Day 1) up to Week 56
Number of Participants With AEs Leading to Premature Discontinuation of Study Drug
Lasso di tempo: From Baseline (Day 1) up to Week 52
Number of participants with AEs leading to premature discontinuation of study drug was reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
From Baseline (Day 1) up to Week 52
Number of Participants With TEAEs of Special Interest
Lasso di tempo: From Baseline (Day 1) up to Week 56
Number of participants with TEAEs of special interest was reported. It included anemia/decreased hemoglobin level, oedema/fluid retention, hepatic impairment and hypotension. TEAEs are defined as any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days.
From Baseline (Day 1) up to Week 56
Number of Participants With Postbaseline Markedly Abnormal Hematology Laboratory Values
Lasso di tempo: Weeks 20, 40, 52
Number of participants with postbaseline markedly abnormal hematology laboratory values was reported. It included Hematocrit:<0.28% of blood cells (<0.32M[%]), Hemoglobin: < 100 grams per liter (g/L), Leukocytes: <3.0 10^9 cells per Liter (L), and Leukocytes: <3.0 10^9 cells/L. Abnormality was judged at the discretion of investigator. Data is reported for categories where at least one participant had abnormality.
Weeks 20, 40, 52
Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Potassium and Calcium
Lasso di tempo: Week 4
Number of participants with postbaseline markedly abnormal clinical chemistry laboratory values was reported. It included Potassium: >6.0 millimoles per liter (mmol/L) and Calcium: <1.75 mmol/L. Abnormality was judged at the discretion of investigator. Data is reported for categories where at least one participant had abnormality.
Week 4
Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Alkaline Phosphatase (ALP)
Lasso di tempo: Week 28
Number of participants with postbaseline markedly abnormal clinical chemistry laboratory values (ALP) was reported. It included Alkaline Phosphatase (ALP): > 2.5 * Upper Limit of Normal (ULN). Abnormality was judged at the discretion of investigator. Participants were assessed at Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52. Data is reported for categories where at least one participant had abnormality at any time point: Weeks 20, 40, and 52 reported.
Week 28
Change From Baseline in Hematology Parameters: Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, and Basophils
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameters: platelets, leukocytes, lymphocytes, monocytes, eosinophils, and basophils was reported. Data for each parameters was planned to be reported at specified timepoints only.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Hematology Parameter: Hematocrit
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameter: hematocrit was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Hematology Parameters: Hemoglobin
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameter: hemoglobin was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Hematology Parameter: Erythrocytes
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameter: erythrocytes was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Sodium, Potassium, Urea Nitrogen, Glucose, and Calcium
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameters: sodium, potassium, urea nitrogen, glucose, and calcium was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Creatinine (Jaffe Reaction), Bilirubin, and Direct Bilirubin
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameters: Creatinine, bilirubin, and direct bilirubin was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameter: Creatinine Clearance
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameter: creatinine clearance was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Glomerular Filtration Rate (GFR) From Cystatin C Adjusted for Body Surface Area (BSA)
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameter: GFR from Cystatin C Adjusted for BSA was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP)
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameters: AST, ALT, and ALP was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Vital Signs: Blood Pressure
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in vital signs: blood pressure was reported. It included systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Vital Signs: Pulse Rate
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in vital signs: pulse rate was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline in ECG: heart rate was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline in Electrocardiogram (ECG) Parameter: PR, QRS, QT, Corrected QT Interval-Bazett's Formula (QTcB), and Corrected QT Interval-Fridericia's Formula (QTcF)
Lasso di tempo: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline in ECG: PR, QRS, QT, QTcB, and QTcF intervals was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Plasma Concentration of Macitentan: Participants >=2 Years Old
Lasso di tempo: Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma concentration of macitentan was reported.
Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma Concentration of Aprocitentan (Active Metabolite): Participants >=2 Years Old
Lasso di tempo: Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma concentration of aprocitentan was reported.
Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma Concentration of Macitentan: Participants <2 Years Old
Lasso di tempo: Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
Plasma concentration of macitentan was reported.
Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
Plasma Concentration of Aprocitentan (Active Metabolite): Participants <2 Years Old
Lasso di tempo: Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
Plasma concentration of aprocitentan was reported.
Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Pharmaceutical K.K.

Investigatori

  • Direttore dello studio: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 novembre 2022

Completamento primario (Effettivo)

23 agosto 2024

Completamento dello studio (Effettivo)

5 marzo 2025

Date di iscrizione allo studio

Primo inviato

24 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

21 dicembre 2021

Primo Inserito (Effettivo)

22 dicembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR109128
  • 67896062PAH3001 (Altro identificatore: Janssen Research & Development, LLC)
  • 2023-000984-30 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

La politica di condivisione dei dati delle società farmaceutiche Janssen di Johnson & Johnson è disponibile all'indirizzo www.janssen.com/clinical-trials/transparency. Come indicato su questo sito, le richieste di accesso ai dati dello studio possono essere inviate tramite il sito del progetto Yale Open Data Access (YODA) all'indirizzo yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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