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Une étude sur le macitentan chez des participants pédiatriques japonais souffrant d'hypertension artérielle pulmonaire

16 avril 2026 mis à jour par: Janssen Pharmaceutical K.K.

Une étude multicentrique, ouverte, de phase III pour évaluer l'efficacité, l'innocuité et la pharmacocinétique du macitentan chez des patients pédiatriques japonais (>= 3 mois à

Le but de cette étude est d'évaluer l'effet du macitentan sur les mesures hémodynamiques à la semaine 24 dans des populations pédiatriques.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

7

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

3 mois à 15 ans (Enfant)

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Hypertension artérielle pulmonaire (HTAP) appartenant au groupe 1 de la classification de Nice mise à jour en 2013
  • Diagnostic d'HTAP confirmé par un cathétérisme cardiaque droit historique où, en l'absence d'obstruction de la veine pulmonaire et/ou de maladie pulmonaire importante, la pression artérielle pulmonaire (PAWP) peut être remplacée par la pression de l'oreillette gauche (LAP) ou la pression télédiastolique du ventricule gauche (LVEDP) (en absence de sténose mitrale) évaluée par cathétérisme cardiaque
  • Classe fonctionnelle (FC) I à IV de l'Organisation mondiale de la santé (OMS)
  • Participants naïfs de traitement spécifiques à l'HTAP ou participants sous traitement spécifique à l'HTAP
  • Une femme en âge de procréer doit avoir un test négatif de bêta-gonadotrophine chorionique humaine (bêta-hCG) sérique hautement sensible lors du dépistage et un test de grossesse urinaire négatif lors de la première administration de l'intervention à l'étude
  • Une participante ne doit pas tomber enceinte et doit accepter de ne pas donner d'ovules pendant l'étude et pendant une période pouvant aller jusqu'à 4 semaines après la fin de l'étude

Critère d'exclusion:

  • Participants atteints d'HTAP due à une hypertension portale, une schistosomiase, une maladie veino-occlusive pulmonaire et/ou une hémangiomatose capillaire pulmonaire et une hypertension pulmonaire persistante du nouveau-né
  • Participants atteints des maladies suivantes : sténose de la veine pulmonaire ; dysplasie bronchopulmonaire
  • Insuffisance hépatique sévère, par exemple, classe C de Child-Pugh, lors du dépistage
  • Enceinte, ou allaitement, ou planifiant de devenir enceinte pendant son inscription à cette étude ou dans les 4 semaines après la dernière dose de l'intervention de l'étude
  • Allergies, hypersensibilité ou intolérance connues au macitentan ou à ses excipients
  • Participant atteint d'HTAP associée à des shunts ouverts, à des anomalies cardiaques congénitales telles qu'un cœur univentriculaire, à une hypertension pulmonaire due à une maladie pulmonaire et à un dysfonctionnement rénal

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Macitentan
Les participants recevront une dose orale de macitentan en fonction de leur âge et de leur poids jusqu'à la semaine 52.
Médicament: Macitentan
Le macitentan sera administré par voie orale sous forme de comprimé.
Autres noms:
  • OPSUMIT
  • ZEPENDO

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changement multiplié par rapport à la valeur initiale à la semaine 24 de l'indice de résistance vasculaire pulmonaire (PVRI)
Délai: Référence (jour 1), semaine 24
Le facteur de variation du PVRI à la semaine 24 a été calculé comme étant de 100* (PVRI à la semaine 24 divisé par le PVRI au départ). La RVP a été déterminée par cathétérisme cardiaque droit.
Référence (jour 1), semaine 24
Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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])
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Janssen Pharmaceutical K.K.

Les enquêteurs

  • Directeur d'études: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 novembre 2022

Achèvement primaire (Réel)

23 août 2024

Achèvement de l'étude (Réel)

5 mars 2025

Dates d'inscription aux études

Première soumission

24 novembre 2021

Première soumission répondant aux critères de contrôle qualité

21 décembre 2021

Première publication (Réel)

22 décembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CR109128
  • 67896062PAH3001 (Autre identifiant: Janssen Research & Development, LLC)
  • 2023-000984-30 (Numéro EudraCT)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

La politique de partage des données des sociétés pharmaceutiques Janssen de Johnson & Johnson est disponible sur www.janssen.com/clinical-trials/transparency. Comme indiqué sur ce site, les demandes d'accès aux données de l'étude peuvent être soumises via le site du projet Yale Open Data Access (YODA) à l'adresse yoda.yale.edu

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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