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A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Macitentan
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

3 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pulmonary arterial hypertension (PAH) belonging to the nice 2013 updated classification group 1
  • PAH diagnosis confirmed by historical right heart catheterization where in the absence of pulmonary vein obstruction and/or significant lung disease pulmonary artery wedge pressure (PAWP) can be replaced by left atrium pressure (LAP) or left ventricular end diastolic pressure (LVEDP) (in absence of mitral stenosis) assessed by heart catheterization
  • World Health Organization (WHO) functional class (FC) I to IV
  • PAH-specific treatment-naïve participants or participants on PAH-specific treatment
  • A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) test at screening and a negative urine pregnancy test at the first administration of study intervention
  • A female participant must not get pregnant and must agree not to donate eggs during the study and for a period of up to 4 weeks following the end of study

Exclusion Criteria:

  • Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn
  • Participants with the following diseases: pulmonary vein stenosis; bronchopulmonary dysplasia
  • Severe hepatic impairment, example, Child-Pugh Class C, at screening
  • Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 weeks after the last dose of study intervention
  • Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
  • Participant with PAH associated with open shunts, with congenital cardiac abnormalities such as univentricular heart, with pulmonary hypertension due to lung disease, and renal dysfunction

Sites / Locations

  • Nagano Children's Hospital
  • Tokyo Medical and Dental University HospitalRecruiting
  • Fukuoka Children's HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Toho University Medical Center Omori HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • National Center for Child Health and DevelopmentRecruiting
  • Tokyo Women's Medical University HospitalRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • Osaka University HospitalRecruiting
  • The University of Tokyo HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Macitentan

Arm Description

Participants will receive oral dose of macitentan based on age and weight through Week 52.

Outcomes

Primary Outcome Measures

Fold Change in Pulmonary Vascular Resistance Index (PVRI)
PVRI fold change at Week 24 is calculated as 100*(PVRI at Week 24 divided by PVRI at baseline).

Secondary Outcome Measures

Change from Baseline at Week 24 in Pulmonary Vascular Resistance (PVR)
Change from baseline at Week 24 in PVR as a part of pulmonary hemodynamic parameter will be reported.
Change from Baseline at Week 24 in Mean Right Atrial Pressure (mRAP)
Change from baseline at Week 24 in mRAP as a part of pulmonary hemodynamic parameter will be reported.
Change from Baseline at Week 24 in Mean Pulmonary Arterial Pressure (mPAP)
Change from baseline at Week 24 in mPAP as a part of pulmonary hemodynamic parameter will be reported. mPAP is calculated as (2*diastolic pulmonary arterial pressure plus systolic pulmonary arterial pressure) divided by 3.
Change from Baseline at Week 24 in Cardiac Index (CI)
Change from baseline at Week 24 in CI will be reported. CI is calculated as cardiac output divided by body surface area.
Change from Baseline at Week 24 in Cardiac Output (CO)
The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute.
Change from Baseline at Week 24 in Total Pulmonary Resistance (TPR)
TPR is a measured hydrodynamic parameter. Change from baseline at Week 24 in TPR will be reported.
Change from Baseline at Week 24 in Mixed Venous Oxygen Saturation (SvO2) at Rest
SvO2 is a measured hydrodynamic parameter. Change from baseline at Week 24 in Svo2 at rest will be reported.
Improvement in World Health Organization (WHO) Functional Class (FC) from Baseline at Week 24
Improvement in WHO FC from baseline at Week 24 will be assessed as per the low (I, II), intermediate (III), and high-risk category (IV).
Improvement in Panama FC from Baseline at Week 24
Improvement in Panama FC from baseline at Week 24 will be assessed as per the low (I, II), intermediate (III), and high-risk category (IV).
Change from Baseline at Week 24 in Exercise Capacity (6-Minute Walk Distance [6MWD] as Measured by the 6-Minute walk Test [6MWT]).
The 6MWT is a non-encouraged test that measures the distance covered by the participant during a 6-minute walk in developmentally capable children equal or above 6 years of age.
Change from Baseline at Week 24 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The quantitation of NT-proBNP plasma levels will be performed and reported.
Change from Baseline at Week 24 in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Echocardiography
TAPSE is a dimension used to evaluate right ventricle (RV) longitudinal systolic function; it measures the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex.
Change from Baseline at Week 24 in Left Ventricular Eccentricity Index (LVEI) Measured by Echocardiography
For LVEI, left ventricle (LV) internal diameters will be measured and recorded in millimeter (mm) with up to 1 decimal place, using the parasternal short axis view at the level of the papillary muscles.
Change from Baseline at Week 24 in Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) Generic Core Scales Short Form (SF-15)
The PedsQL 4.0 SF-15 is a questionnaire for quality of life assessment which will assess the general physical, emotional, social and school functioning (15 questions). The questionnaires are adapted for different age groups: toddlers (2-4 years of age), young children (5-7 years of age), children (8-12 years of age), and adolescents (13-14 years of age). It is rated on the scale of 0 to 4 where 0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always.
Change from Baseline at Week 24 in Physical Activity as Measured by Accelerometry
The physical activity (counts/minute) of the participant is assessed via accelerometer. It is used as a tool to assess functional capacity, disease severity, and prognosis.
Plasma Concentration of Macitentan and Aprocitentan
Plasma concentration of macitentan and active metabolite (aprocitentan) at all assessed timepoints will be reported.
Change from Baseline to all Assessed Timepoints in Exercise Capacity (6MWD, as Measured by the 6MWT)
Change from baseline to all assessed timepoints in exercise capacity (6MWD, as measured by the 6MWT) will be reported.
Change from Baseline to all Assessed Timepoints in Dyspnea on Exertion Assessed by the Borg CR10 Scale
Dyspnea on exertion will be assessed by the Borg CR10 scale. The scale is used to assess how strong participant's perception of dyspnea and level of exertion is. It ranges from "Very weak", that is 1, to "Extremely strong", that is 10. If perception or feeling is stronger than 10, "Maximal" - it can vary beyond 10, example, 12 or still higher (that's why "Absolute maximum" is marked with a dot "•").
Change from Baseline to all Assessed Timepoints in Physical Activity as Measured by Accelerometry
Change from baseline to all assessed timepoints in physical activity as measured by accelerometry will be reported. The physical activity (counts/minute) of the participant is assessed via accelerometer. It is used as a tool to assess functional capacity, disease severity, and prognosis.
Improvement in WHO FC from Baseline to all Assessed Timepoints
Improvement in WHO FC from baseline to all assessed timepoints will be reported.
Improvement in Panama FC from Baseline to all Assessed Timepoints
Improvement in Panama FC from baseline to all assessed timepoints will be reported.
Percent Change from Baseline in Plasma NT-proBNP at Each Timepoint of Assessment
Percent change from baseline in plasma NT-proBNP at each timepoint of assessment will be reported.
Percent Change from Baseline in TAPSE Measured by Echocardiography to all Assessed Timepoints
Percent change from baseline in TAPSE measured by echocardiography to all assessed timepoints will be reported.
Percent Change from Baseline in LVEI Measured by Echocardiography to all Assessed Timepoints
Percent change from baseline in LVEI measured by echocardiography to all assessed timepoints will be reported.
Change from Baseline to all Assessed Timepoints in PedsQL 4.0 Generic Core Scales Short Form (SF-15)
Change from baseline to all assessed timepoints in PedsQL 4.0 Generic Core Scales Short Form (SF-15) will be reported.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Number of Participants with AEs Leading to Premature Discontinuation of Macitentan
Number of participants with AEs leading to premature discontinuation of macitentan will be reported.
Number of Participants with AEs of Special Interests (AESIs)
Number of participants with AESIs will be reported. AESI in this study are: anemia/decreased hemoglobin level, edema/fluid retention, hepatic impairment/ alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase, and hypotension.
Number of Participants with Clinical Safety Laboratory Abnormalities
Number of participants with clinical safety laboratory abnormalities (including serum chemistry, hematology, and urinalysis) will be reported.
Number of Participants with Change from Baseline in Laboratory Parameters to all Timepoints of Assessments
Number of participants with change from baseline in laboratory parameters (including serum chemistry, hematology, and urinalysis) to all timepoints of assessments will be reported.
Number of Participants with Change from Baseline in Vital Signs to all Timepoints of Assessments
Number of participants with change from baseline in vital signs (including diastolic blood pressure [DBP], systolic blood pressure [SBP], and pulse rate [PR], height, and body weight) to all timepoints of assessments will be reported.
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Number of participants with change from baseline in ECG parameters will be reported.

Full Information

First Posted
November 24, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT05167825
Brief Title
A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
Official Title
A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
March 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Macitentan
Arm Type
Experimental
Arm Description
Participants will receive oral dose of macitentan based on age and weight through Week 52.
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
OPSUMIT, ZEPENDO
Intervention Description
Macitentan will be administered orally as a tablet.
Primary Outcome Measure Information:
Title
Fold Change in Pulmonary Vascular Resistance Index (PVRI)
Description
PVRI fold change at Week 24 is calculated as 100*(PVRI at Week 24 divided by PVRI at baseline).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline at Week 24 in Pulmonary Vascular Resistance (PVR)
Description
Change from baseline at Week 24 in PVR as a part of pulmonary hemodynamic parameter will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Mean Right Atrial Pressure (mRAP)
Description
Change from baseline at Week 24 in mRAP as a part of pulmonary hemodynamic parameter will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Mean Pulmonary Arterial Pressure (mPAP)
Description
Change from baseline at Week 24 in mPAP as a part of pulmonary hemodynamic parameter will be reported. mPAP is calculated as (2*diastolic pulmonary arterial pressure plus systolic pulmonary arterial pressure) divided by 3.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Cardiac Index (CI)
Description
Change from baseline at Week 24 in CI will be reported. CI is calculated as cardiac output divided by body surface area.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Cardiac Output (CO)
Description
The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Total Pulmonary Resistance (TPR)
Description
TPR is a measured hydrodynamic parameter. Change from baseline at Week 24 in TPR will be reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Mixed Venous Oxygen Saturation (SvO2) at Rest
Description
SvO2 is a measured hydrodynamic parameter. Change from baseline at Week 24 in Svo2 at rest will be reported.
Time Frame
Baseline and Week 24
Title
Improvement in World Health Organization (WHO) Functional Class (FC) from Baseline at Week 24
Description
Improvement in WHO FC from baseline at Week 24 will be assessed as per the low (I, II), intermediate (III), and high-risk category (IV).
Time Frame
Baseline and Week 24
Title
Improvement in Panama FC from Baseline at Week 24
Description
Improvement in Panama FC from baseline at Week 24 will be assessed as per the low (I, II), intermediate (III), and high-risk category (IV).
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Exercise Capacity (6-Minute Walk Distance [6MWD] as Measured by the 6-Minute walk Test [6MWT]).
Description
The 6MWT is a non-encouraged test that measures the distance covered by the participant during a 6-minute walk in developmentally capable children equal or above 6 years of age.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Description
The quantitation of NT-proBNP plasma levels will be performed and reported.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Tricuspid Annular Plane Systolic Excursion (TAPSE) Measured by Echocardiography
Description
TAPSE is a dimension used to evaluate right ventricle (RV) longitudinal systolic function; it measures the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Left Ventricular Eccentricity Index (LVEI) Measured by Echocardiography
Description
For LVEI, left ventricle (LV) internal diameters will be measured and recorded in millimeter (mm) with up to 1 decimal place, using the parasternal short axis view at the level of the papillary muscles.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) Generic Core Scales Short Form (SF-15)
Description
The PedsQL 4.0 SF-15 is a questionnaire for quality of life assessment which will assess the general physical, emotional, social and school functioning (15 questions). The questionnaires are adapted for different age groups: toddlers (2-4 years of age), young children (5-7 years of age), children (8-12 years of age), and adolescents (13-14 years of age). It is rated on the scale of 0 to 4 where 0=never, 1=almost never, 2=sometimes, 3=often, and 4=almost always.
Time Frame
Baseline and Week 24
Title
Change from Baseline at Week 24 in Physical Activity as Measured by Accelerometry
Description
The physical activity (counts/minute) of the participant is assessed via accelerometer. It is used as a tool to assess functional capacity, disease severity, and prognosis.
Time Frame
Baseline and Week 24
Title
Plasma Concentration of Macitentan and Aprocitentan
Description
Plasma concentration of macitentan and active metabolite (aprocitentan) at all assessed timepoints will be reported.
Time Frame
Day 1 and Week 12
Title
Change from Baseline to all Assessed Timepoints in Exercise Capacity (6MWD, as Measured by the 6MWT)
Description
Change from baseline to all assessed timepoints in exercise capacity (6MWD, as measured by the 6MWT) will be reported.
Time Frame
Baseline up to Week 52
Title
Change from Baseline to all Assessed Timepoints in Dyspnea on Exertion Assessed by the Borg CR10 Scale
Description
Dyspnea on exertion will be assessed by the Borg CR10 scale. The scale is used to assess how strong participant's perception of dyspnea and level of exertion is. It ranges from "Very weak", that is 1, to "Extremely strong", that is 10. If perception or feeling is stronger than 10, "Maximal" - it can vary beyond 10, example, 12 or still higher (that's why "Absolute maximum" is marked with a dot "•").
Time Frame
Baseline up to Week 52
Title
Change from Baseline to all Assessed Timepoints in Physical Activity as Measured by Accelerometry
Description
Change from baseline to all assessed timepoints in physical activity as measured by accelerometry will be reported. The physical activity (counts/minute) of the participant is assessed via accelerometer. It is used as a tool to assess functional capacity, disease severity, and prognosis.
Time Frame
Baseline up to Week 52
Title
Improvement in WHO FC from Baseline to all Assessed Timepoints
Description
Improvement in WHO FC from baseline to all assessed timepoints will be reported.
Time Frame
Baseline up to Week 52
Title
Improvement in Panama FC from Baseline to all Assessed Timepoints
Description
Improvement in Panama FC from baseline to all assessed timepoints will be reported.
Time Frame
Baseline up to Week 52
Title
Percent Change from Baseline in Plasma NT-proBNP at Each Timepoint of Assessment
Description
Percent change from baseline in plasma NT-proBNP at each timepoint of assessment will be reported.
Time Frame
Baseline up to Week 52
Title
Percent Change from Baseline in TAPSE Measured by Echocardiography to all Assessed Timepoints
Description
Percent change from baseline in TAPSE measured by echocardiography to all assessed timepoints will be reported.
Time Frame
Baseline up to Week 52
Title
Percent Change from Baseline in LVEI Measured by Echocardiography to all Assessed Timepoints
Description
Percent change from baseline in LVEI measured by echocardiography to all assessed timepoints will be reported.
Time Frame
Baseline up to Week 52
Title
Change from Baseline to all Assessed Timepoints in PedsQL 4.0 Generic Core Scales Short Form (SF-15)
Description
Change from baseline to all assessed timepoints in PedsQL 4.0 Generic Core Scales Short Form (SF-15) will be reported.
Time Frame
Baseline up to Week 52
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to 3 years
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Time Frame
Up to 3 years
Title
Number of Participants with AEs Leading to Premature Discontinuation of Macitentan
Description
Number of participants with AEs leading to premature discontinuation of macitentan will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with AEs of Special Interests (AESIs)
Description
Number of participants with AESIs will be reported. AESI in this study are: anemia/decreased hemoglobin level, edema/fluid retention, hepatic impairment/ alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase, and hypotension.
Time Frame
Up to 3 years
Title
Number of Participants with Clinical Safety Laboratory Abnormalities
Description
Number of participants with clinical safety laboratory abnormalities (including serum chemistry, hematology, and urinalysis) will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Change from Baseline in Laboratory Parameters to all Timepoints of Assessments
Description
Number of participants with change from baseline in laboratory parameters (including serum chemistry, hematology, and urinalysis) to all timepoints of assessments will be reported.
Time Frame
Baseline up to 3 years
Title
Number of Participants with Change from Baseline in Vital Signs to all Timepoints of Assessments
Description
Number of participants with change from baseline in vital signs (including diastolic blood pressure [DBP], systolic blood pressure [SBP], and pulse rate [PR], height, and body weight) to all timepoints of assessments will be reported.
Time Frame
Baseline up to 3 years
Title
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Description
Number of participants with change from baseline in ECG parameters will be reported.
Time Frame
Baseline up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pulmonary arterial hypertension (PAH) belonging to the nice 2013 updated classification group 1 PAH diagnosis confirmed by historical right heart catheterization where in the absence of pulmonary vein obstruction and/or significant lung disease pulmonary artery wedge pressure (PAWP) can be replaced by left atrium pressure (LAP) or left ventricular end diastolic pressure (LVEDP) (in absence of mitral stenosis) assessed by heart catheterization World Health Organization (WHO) functional class (FC) I to IV PAH-specific treatment-naïve participants or participants on PAH-specific treatment A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) test at screening and a negative urine pregnancy test at the first administration of study intervention A female participant must not get pregnant and must agree not to donate eggs during the study and for a period of up to 4 weeks following the end of study Exclusion Criteria: Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn Participants with the following diseases: pulmonary vein stenosis; bronchopulmonary dysplasia Severe hepatic impairment, example, Child-Pugh Class C, at screening Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 weeks after the last dose of study intervention Known allergies, hypersensitivity, or intolerance to macitentan or its excipients Participant with PAH associated with open shunts, with congenital cardiac abnormalities such as univentricular heart, with pulmonary hypertension due to lung disease, and renal dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Nagano Children's Hospital
City
Azumino-shi, Nagano
ZIP/Postal Code
399-8288
Country
Japan
Individual Site Status
Completed
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka Children's Hospital
City
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toho University Medical Center Omori Hospital
City
Ota
ZIP/Postal Code
143-8541
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Child Health and Development
City
Setagaya-ku
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-Shi
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
The University of Tokyo Hospital
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

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