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Tutkimus Macitentaanista japanilaisista lapsipotilaista, joilla on keuhkovaltimohypertensio

torstai 16. huhtikuuta 2026 päivittänyt: Janssen Pharmaceutical K.K.

Monikeskus, avoin, vaiheen III tutkimus Macitentanin tehon, turvallisuuden ja farmakokinetiikkaa arvioimiseksi japanilaisilla lapsipotilailla (>= 3 kuukautta

Tämän tutkimuksen tarkoituksena on arvioida macitentaanin vaikutusta hemodynaamisiin mittauksiin viikolla 24 lapsipotilailla.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

7

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

3 kuukautta - 15 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Keuhkoverenpainetauti (PAH), joka kuuluu mukavaan 2013 päivitettyyn luokitusryhmään 1
  • PAH-diagnoosi vahvistetaan historiallisella oikean sydämen katetroinnilla, jossa keuhkolaskimotukoksen ja/tai merkittävän keuhkosairauden puuttuessa keuhkovaltimon kiilapaine (PAWP) voidaan korvata vasemman eteisen paineella (LAP) tai vasemman kammion loppudiastolisella paineella (LVEDP) mitraalistenoosin puuttuminen) arvioituna sydämen katetroinnilla
  • Maailman terveysjärjestön (WHO) toimintaluokka (FC) I–IV
  • PAH-spesifistä hoitoa aiemmin saaneet osallistujat tai PAH-spesifistä hoitoa saavat osallistujat
  • Hedelmällisessä iässä olevalla naisella on oltava negatiivinen erittäin herkkä seerumin beeta-ihmisen koriongonadotropiini (beeta-hCG) -testi seulonnassa ja negatiivinen virtsan raskaustesti tutkimuksen ensimmäisen annon yhteydessä
  • Naispuolinen osallistuja ei saa tulla raskaaksi ja hänen on suostuttava olemaan luovuttamatta munasoluja tutkimuksen aikana ja enintään 4 viikon ajan tutkimuksen päättymisen jälkeen

Poissulkemiskriteerit:

  • Osallistujat, joilla on portaaliverenpaineen, skitosomiaasin, keuhkolaskimotukoksen ja/tai keuhkokapillaarihemangiomatoosin aiheuttama PAH ja vastasyntyneen jatkuva keuhkoverenpaine.
  • Osallistujat, joilla on seuraavat sairaudet: keuhkolaskimostenoosi; bronkopulmonaalinen dysplasia
  • Vaikea maksan vajaatoiminta, esimerkiksi Child-Pugh-luokka C, seulonnassa
  • raskaana, imetät tai suunnittelet raskautta osallistuessasi tähän tutkimukseen tai 4 viikon sisällä viimeisen tutkimustoimenpiteen annoksen jälkeen
  • Tunnetut allergiat, yliherkkyys tai intoleranssi macitentaanille tai sen apuaineille
  • Osallistuja, jolla on avoimiin shuntteihin liittyvä PAH, synnynnäisiä sydämen poikkeavuuksia, kuten yksikammioinen sydän, keuhkosairaudesta johtuva keuhkoverenpainetauti ja munuaisten toimintahäiriö

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Macitentan
Osallistujat saavat suun kautta ikään ja painoon perustuvaa macitentaania viikon 52 ajan.
Lääke: Macitentan
Macitentan annetaan suun kautta tablettina.
Muut nimet:
  • OPSUMIT
  • ZEPENDO

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Keuhkojen verisuoniresistenssiindeksin (PVRI) taittuminen lähtötasosta viikolla 24
Aikaikkuna: Lähtötilanne (päivä 1), viikko 24
PVRI-kertymän muutos viikolla 24 laskettiin 100* (PVRI viikolla 24 jaettuna PVRI:llä lähtötilanteessa). PVR määritettiin oikean sydämen katetroinnilla.
Lähtötilanne (päivä 1), viikko 24
Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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])
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Janssen Pharmaceutical K.K.

Tutkijat

  • Opintojohtaja: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 14. marraskuuta 2022

Ensisijainen valmistuminen (Todellinen)

Perjantai 23. elokuuta 2024

Opintojen valmistuminen (Todellinen)

Keskiviikko 5. maaliskuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 24. marraskuuta 2021

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 21. joulukuuta 2021

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 22. joulukuuta 2021

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 7. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 16. huhtikuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. huhtikuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CR109128
  • 67896062PAH3001 (Muu tunniste: Janssen Research & Development, LLC)
  • 2023-000984-30 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Johnson & Johnsonin Janssen Pharmaceutical Companiesin tiedonjakopolitiikka on saatavilla osoitteessa www.janssen.com/clinical-trials/transparency. Kuten tällä sivustolla mainitaan, tutkimustietoihin pääsyä koskevat pyynnöt voidaan lähettää Yale Open Data Access (YODA) -projektisivuston kautta osoitteessa yoda.yale.edu

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Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

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