Um estudo de Macitentan em participantes pediátricos japoneses com hipertensão arterial pulmonar
16 de abril de 2026 atualizado por: Janssen Pharmaceutical K.K.
Um estudo multicêntrico, aberto, de Fase III para avaliar a eficácia, segurança e farmacocinética de Macitentan em pacientes pediátricos japoneses (>=3 meses a
O objetivo deste estudo é avaliar o efeito do macitentan nas medidas hemodinâmicas na semana 24 em populações pediátricas.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
7
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Azumino-shi, Japão, 399-8288
- Nagano Children's Hospital
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Bunkyō City, Japão, 113 8519
- Institute of Science Tokyo Hospital
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Fukuoka, Japão, 813-0017
- Fukuoka Children's Hospital
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Okayama, Japão, 700 8558
- Okayama University Hospital
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Sapporo, Japão, 060-8648
- Hokkaido University Hospital
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Setagaya Ku, Japão, 157 8535
- National Center for Child Health and Development
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Shinjuku-ku, Japão, 162-8666
- Tokyo Women's Medical University Hospital
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Suita-Shi, Japão, 564-8565
- National Cerebral and Cardiovascular Center
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Suita-shi, Japão, 565-0871
- Osaka University Hospital
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Tokyo, Japão, 113-8655
- The University of Tokyo Hospital
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Ōta-ku, Japão, 143-8541
- Toho University Medical Center Omori Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
3 meses a 15 anos (Filho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Hipertensão arterial pulmonar (HAP) pertencente ao grupo 1 da classificação atualizada de Nice 2013
- O diagnóstico de HAP confirmado por cateterismo cardíaco direito histórico onde, na ausência de obstrução da veia pulmonar e/ou doença pulmonar significativa, a pressão arterial pulmonar (PAWP) pode ser substituída pela pressão do átrio esquerdo (LAP) ou pressão diastólica final do ventrículo esquerdo (LVEDP) (em ausência de estenose mitral) avaliada por cateterismo cardíaco
- Organização Mundial da Saúde (OMS) classe funcional (CF) I a IV
- Participantes virgens de tratamento específico para HAP ou participantes em tratamento específico para HAP
- Uma mulher em idade fértil deve ter um teste de beta-gonadotrofina coriônica humana (beta-hCG) sérico altamente sensível negativo na triagem e um teste de gravidez de urina negativo na primeira administração da intervenção do estudo
- Uma participante do sexo feminino não deve engravidar e deve concordar em não doar óvulos durante o estudo e por um período de até 4 semanas após o final do estudo
Critério de exclusão:
- Participantes com HAP por hipertensão portal, esquistossomose, doença veno-oclusiva pulmonar e/ou hemangiomatose capilar pulmonar e hipertensão pulmonar persistente do recém-nascido
- Participantes com as seguintes doenças: estenose de veia pulmonar; displasia broncopulmonar
- Insuficiência hepática grave, por exemplo, Child-Pugh Classe C, na triagem
- Grávida ou amamentando ou planejando engravidar enquanto incluída neste estudo ou dentro de 4 semanas após a última dose da intervenção do estudo
- Alergias, hipersensibilidade ou intolerância conhecidas ao macitentan ou seus excipientes
- Participante com HAP associada a shunts abertos, com anormalidades cardíacas congênitas, como coração univentricular, com hipertensão pulmonar devido a doença pulmonar e disfunção renal
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Macitentan
Os participantes receberão dose oral de macitentan com base na idade e peso até a semana 52.
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Macitentan será administrado por via oral na forma de comprimido.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Dobre a alteração da linha de base na semana 24 no índice de resistência vascular pulmonar (PVRI)
Prazo: Linha de base (dia 1), semana 24
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A alteração da dobra do PVRI na Semana 24 foi calculada como 100*(PVRI na Semana 24 dividido pelo PVRI no início do estudo).
A RVP foi determinada por cateterismo cardíaco direito.
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Linha de base (dia 1), semana 24
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Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
Prazo: Baseline (Day 1), Weeks 8, 16, 20, 40, 52
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Change from baseline in hematology parameters: NBF was reported.
Data for each parameters was planned to be reported at specified timepoints only.
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Baseline (Day 1), Weeks 8, 16, 20, 40, 52
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
Prazo: Baseline (Day 1), Week 24
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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].
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Mean Right Atrial Pressure (mRAP)
Prazo: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: mRAP was reported.
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Mean Pulmonary Arterial Pressure (mPAP)
Prazo: Baseline (Day 1), Week 24
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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.
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Index (CI)
Prazo: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: CI was reported.
CI was calculated as: CO/Body surface area (BSA).
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Output (CO)
Prazo: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: CO was reported.
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Total Pulmonary Resistance (TPR)
Prazo: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: TPR was reported.
TPR was calculated as: (mPAP/CO)*80.
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Baseline (Day 1), Week 24
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Percent Change From Baseline to Week 24 in Hemodynamic Variable: Mixed Venous Oxygen Saturation (SvO[2])
Prazo: Baseline (Day 1), Week 24
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Percent change from baseline to Week 24 in hemodynamic variable: SvO(2) was reported.
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Baseline (Day 1), Week 24
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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)
Prazo: Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
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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.
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Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
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Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama Functional Class (FC)
Prazo: Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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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.
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Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline to Weeks 24 and 52 in 6-minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT)
Prazo: Baseline (Day 1), Weeks 24 and 52
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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.
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Baseline (Day 1), Weeks 24 and 52
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Change From Baseline to Weeks 12, 24, 28, 40, and 52 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Prazo: Baseline (Day 1), Week 12, 24, 28, 40, and 52
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Change from baseline to Weeks 12, 24, 28, 40, and 52 in NT-proBNP was reported.
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Baseline (Day 1), Week 12, 24, 28, 40, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Week 12, 24, and 52 in Left Ventricular Eccentricity Index (LVEI)
Prazo: Baseline (Day 1), Weeks 12, 24 and 52
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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.
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Baseline (Day 1), Weeks 12, 24 and 52
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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)
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Number of Hours of Daytime Activity
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: number of hours of daytime activity was reported.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Count Per Minute of Daily Activity
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Light Physical Activity
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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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
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Week 24 and Week 52 in Borg Dyspnea Index (BDI)
Prazo: Baseline (Day 1), Weeks 24 and 52
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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.
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Baseline (Day 1), Weeks 24 and 52
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Prazo: From Baseline (Day 1) up to Week 56
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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.
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From Baseline (Day 1) up to Week 56
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Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Prazo: From Baseline (Day 1) up to Week 56
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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.
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From Baseline (Day 1) up to Week 56
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Number of Participants With AEs Leading to Premature Discontinuation of Study Drug
Prazo: From Baseline (Day 1) up to Week 52
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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.
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From Baseline (Day 1) up to Week 52
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Number of Participants With TEAEs of Special Interest
Prazo: From Baseline (Day 1) up to Week 56
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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.
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From Baseline (Day 1) up to Week 56
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Number of Participants With Postbaseline Markedly Abnormal Hematology Laboratory Values
Prazo: Weeks 20, 40, 52
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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.
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Weeks 20, 40, 52
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Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Potassium and Calcium
Prazo: Week 4
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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.
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Week 4
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Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Alkaline Phosphatase (ALP)
Prazo: Week 28
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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.
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Week 28
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Change From Baseline in Hematology Parameters: Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, and Basophils
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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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.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Hematology Parameter: Hematocrit
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in hematology parameter: hematocrit was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Hematology Parameters: Hemoglobin
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in hematology parameter: hemoglobin was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Hematology Parameter: Erythrocytes
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in hematology parameter: erythrocytes was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Sodium, Potassium, Urea Nitrogen, Glucose, and Calcium
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameters: sodium, potassium, urea nitrogen, glucose, and calcium was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Creatinine (Jaffe Reaction), Bilirubin, and Direct Bilirubin
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameters: Creatinine, bilirubin, and direct bilirubin was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameter: Creatinine Clearance
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameter: creatinine clearance was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Glomerular Filtration Rate (GFR) From Cystatin C Adjusted for Body Surface Area (BSA)
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameter: GFR from Cystatin C Adjusted for BSA was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP)
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameters: AST, ALT, and ALP was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Vital Signs: Blood Pressure
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in vital signs: blood pressure was reported.
It included systolic blood pressure (SBP) and diastolic blood pressure (DBP).
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Vital Signs: Pulse Rate
Prazo: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in vital signs: pulse rate was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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Change from baseline in ECG: heart rate was reported.
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Baseline (Day 1), Weeks 12, 24, and 52
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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)
Prazo: Baseline (Day 1), Weeks 12, 24, and 52
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Change from baseline in ECG: PR, QRS, QT, QTcB, and QTcF intervals was reported.
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Baseline (Day 1), Weeks 12, 24, and 52
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Plasma Concentration of Macitentan: Participants >=2 Years Old
Prazo: Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma concentration of macitentan was reported.
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Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma Concentration of Aprocitentan (Active Metabolite): Participants >=2 Years Old
Prazo: Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma concentration of aprocitentan was reported.
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Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma Concentration of Macitentan: Participants <2 Years Old
Prazo: Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Plasma concentration of macitentan was reported.
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Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Plasma Concentration of Aprocitentan (Active Metabolite): Participants <2 Years Old
Prazo: Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Plasma concentration of aprocitentan was reported.
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Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de novembro de 2022
Conclusão Primária (Real)
23 de agosto de 2024
Conclusão do estudo (Real)
5 de março de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
24 de novembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de dezembro de 2021
Primeira postagem (Real)
22 de dezembro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR109128
- 67896062PAH3001 (Outro identificador: Janssen Research & Development, LLC)
- 2023-000984-30 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
A política de compartilhamento de dados da Janssen Pharmaceutical Companies of Johnson & Johnson está disponível em www.janssen.com/clinical-trials/transparency.
Conforme observado neste site, as solicitações de acesso aos dados do estudo podem ser enviadas por meio do site do Projeto Yale Open Data Access (YODA) em yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .