UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060071 |
|---|---|
| Receipt number | R000068698 |
| Scientific Title | A multicenter observational study on the efficacy and safety of selexipag in pediatric pulmonary arterial hypertension |
| Date of disclosure of the study information | 2025/12/12 |
| Last modified on | 2025/12/12 17:10:51 |
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Basic information
Public title
A multicenter observational study on the efficacy and safety of selexipag in pediatric pulmonary arterial hypertension
Acronym
A multicenter observational study of selexipag in pediatric PAH
Scientific Title
A multicenter observational study on the efficacy and safety of selexipag in pediatric pulmonary arterial hypertension
Scientific Title:Acronym
A multicenter observational study of selexipag in pediatric PAH
Region
| Japan |
Condition
Condition
Pediatric pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the real-world outcomes of selexipag in pediatric patients with pulmonary arterial hypertension (PAH) and to explore the association between plasma drug concentration and treatment response.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Efficacy outcomes: changes in the following parameters from achievement of the maximum tolerated dose of selexipag through 24 weeks of follow-up
- Hemodynamic data from catheterization (heart rate, pulmonary vascular resistance index, pulmonary artery pressure (mean, systolic, diastolic), wedge pressure, cardiac index, stroke volume index, mean right atrial pressure, mixed venous oxygen saturation, pulmonary to systemic resistance ratio)
- Echocardiographic parameters (tricuspid regurgitation velocity, tricuspid regurgitation pressure gradient, right ventricular systolic pressure)
- Exercise capacity (NYHA/WHO functional class)
- Other clinical laboratory parameters (brain natriuretic peptide, N-terminal pro-brain natriuretic peptide)
2. Safety outcomes
- Adverse events (headache, diarrhea, jaw pain, nausea, vomiting, flushing)
- Serious adverse events
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following inclusion criteria
1. Patients aged 2 years or older but younger than 15 years
2. Patients who have undergone cardiac catheterization and have been diagnosed with pulmonary arterial hypertension
3. Patients who are newly initiated on selexipag therapy following its regulatory approval
Key exclusion criteria
Patients who meet at least one of the following criteria
1. Patients scheduled to undergo surgical repair during the observation period
2. Patients with Fontan circulation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Takatsuki |
Organization
Toho University Omori Medical Center
Division name
Pediatrics Center (pediatrics)
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
s-taka@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Takatsuki |
Organization
Toho University Omori Medical Center
Division name
Pediatrics Center (pediatrics)
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
s-taka@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku CO., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University Hospital
National Center for Child Health and Development
Tokyo Metropolitan Children's Medical Center
Institute of Science Tokyo Hospital
Keio University Hospital
The University of Osaka Hospital
Nippon Shinyaku Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Faculty of Medicine, Toho University
Address
5-21-16 Omorinishi, Ota-ku, Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to clarify the real-world outcomes of selexipag in pediatric patients with pulmonary arterial hypertension (PAH) and to explore the association between plasma drug concentration and treatment response.
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068698
