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Badanie macytentanu u japońskich uczestników pediatrycznych z tętniczym nadciśnieniem płucnym

16 kwietnia 2026 zaktualizowane przez: Janssen Pharmaceutical K.K.

Wieloośrodkowe, otwarte badanie III fazy mające na celu ocenę skuteczności, bezpieczeństwa i farmakokinetyki macytentanu u japońskich pacjentów pediatrycznych (>= 3 miesiące do

Celem tego badania jest ocena wpływu macytentanu na pomiary hemodynamiczne w 24. tygodniu w populacji pediatrycznej.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

7

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

3 miesiące do 15 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Tętnicze nadciśnienie płucne (TNP) należące do zaktualizowanej w 2013 roku grupy klasyfikacyjnej 1
  • Rozpoznanie TNP potwierdzone przez historyczne cewnikowanie prawego serca, gdzie przy braku niedrożności żyły płucnej i/lub istotnej choroby płuc ciśnienie zaklinowania w tętnicy płucnej (PAWP) można zastąpić ciśnieniem w lewym przedsionku (LAP) lub ciśnieniem końcoworozkurczowym lewej komory (LVEDP) (w brak zwężenia zastawki mitralnej) oceniane przez cewnikowanie serca
  • Klasa funkcjonalna Światowej Organizacji Zdrowia (WHO) (FC) I do IV
  • Uczestnicy, którzy nie byli wcześniej leczeni ze względu na PAH lub uczestnicy leczeni ze względu na PAH
  • Kobieta w wieku rozrodczym musi mieć ujemny bardzo czuły test beta-ludzkiej gonadotropiny kosmówkowej (beta-hCG) w surowicy podczas badania przesiewowego oraz ujemny wynik testu ciążowego z moczu podczas pierwszego podania badanej interwencji
  • Uczestniczka nie może zajść w ciążę i musi wyrazić zgodę na nieoddawanie komórek jajowych w trakcie badania i przez okres do 4 tygodni po zakończeniu badania

Kryteria wyłączenia:

  • Uczestnicy z PAH z powodu nadciśnienia wrotnego, schistosomatozy, choroby zarostowej żył płucnych i/lub naczyniakowatości naczyń włosowatych płuc oraz przetrwałego nadciśnienia płucnego noworodka
  • Uczestnicy z następującymi chorobami: zwężeniem żył płucnych; dysplazja oskrzelowo-płucna
  • Ciężkie zaburzenia czynności wątroby, np. klasa C Child-Pugh, podczas badań przesiewowych
  • Ciąża, karmienie piersią lub planowanie ciąży w trakcie włączenia do tego badania lub w ciągu 4 tygodni po przyjęciu ostatniej dawki interwencji w ramach badania
  • Znane alergie, nadwrażliwość lub nietolerancja na macitentan lub jego substancje pomocnicze
  • Uczestnik z PAH związanym z otwartymi przeciekami, z wrodzonymi wadami serca, takimi jak serce jednokomorowe, z nadciśnieniem płucnym spowodowanym chorobą płuc i dysfunkcją nerek

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Macytentan
Uczestnicy będą otrzymywać doustną dawkę macytentanu w zależności od wieku i masy ciała do tygodnia 52.
Lek: Macytentan
Macytentan będzie podawany doustnie w postaci tabletki.
Inne nazwy:
  • OPSUMIT
  • ZEPENDO

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Krotność zmiany w stosunku do wartości wyjściowych w 24. tygodniu w zakresie wskaźnika oporu naczyniowego płuc (PVRI)
Ramy czasowe: Wartość wyjściowa (dzień 1), tydzień 24
Krotność zmiany PVRI w 24. tygodniu obliczono jako 100* (PVRI w 24. tygodniu podzielone przez PVRI na początku badania). PVR określono na podstawie cewnikowania prawego serca.
Wartość wyjściowa (dzień 1), tydzień 24
Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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])
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen Pharmaceutical K.K.

Śledczy

  • Dyrektor Studium: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 listopada 2022

Zakończenie podstawowe (Rzeczywisty)

23 sierpnia 2024

Ukończenie studiów (Rzeczywisty)

5 marca 2025

Daty rejestracji na studia

Pierwszy przesłany

24 listopada 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 grudnia 2021

Pierwszy wysłany (Rzeczywisty)

22 grudnia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CR109128
  • 67896062PAH3001 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2023-000984-30 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Polityka udostępniania danych Janssen Pharmaceutical Companies of Johnson & Johnson jest dostępna na stronie www.janssen.com/clinical-trials/transparency. Jak wspomniano na tej stronie, wnioski o dostęp do danych z badań można składać za pośrednictwem witryny projektu Yale Open Data Access (YODA) pod adresem yoda.yale.edu

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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