Trial · NCT05167825
A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
NCT05167825, Phase 3, Completed, Janssen Pharmaceutical K.K.; results first posted 2025-10-21
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension. Trials, record NCT05167825. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05167825
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
- NCT number
- NCT05167825
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan
- First posted
- 2021-12-22
- Last updated
- 2026-05-07
- Other registries' IDs
- eudract:2023-000984-30
- Results first posted
- 2025-10-21
- Limitations and caveats
- The interpretation of study results was limited by small sample size of only 7 participants. Study was not controlled, hence no comparison to Standard of Care (or placebo) was possible.
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fold Change From Baseline at Week 24 in Pulmonary Vascular Resistance Index (PVRI) | Baseline (Day 1), Week 24 | PVRI fold change at Week 24 was calculated as 100\*(PVRI at Week 24 divided by PVRI at baseline). PVR was determined by right heart catheterization. |
| Primary | Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF) | 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. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR) | 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 \[CO\]. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Mean Right Atrial Pressure (mRAP) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: mRAP was reported. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Mean Pulmonary Arterial Pressure (mPAP) | 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. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Index (CI) | 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). |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Output (CO) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: CO was reported. |
| Secondary | Change From Baseline to Week 24 in Hemodynamic Variable: Total Pulmonary Resistance (TPR) | Baseline (Day 1), Week 24 | Change from baseline to Week 24 in hemodynamic variable: TPR was reported. TPR was calculated as: (mPAP/CO)\*80. |
| Secondary | Percent Change From Baseline to Week 24 in Hemodynamic Variable: Mixed Venous Oxygen Saturation (SvO[2]) | Baseline (Day 1), Week 24 | Percent change from baseline to Week 24 in hemodynamic variable: SvO(2) was reported. |
| Secondary | 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) | 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. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fold Change From Baseline at Week 24 in Pulmonary Vascular Resistance Index (PVRI) | Baseline (Day 1), Week 24 | Efficacy analysis set included all participants who were administered at least 1 dose of macitentan. | Fold change (percentage) | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline at Week 24 in Hemodynamic Variables: Pulmonary Vascular Resistance (PVR) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline in Mean Right Atrial Pressure (mRAP) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline at Week 24 in Hemodynamic Variables: Mean Pulmonary Arterial Pressure (mPAP) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline at Week 24 in Hemodynamic Variables: Cardiac Index (CI) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline at Week 24 in Hemodynamic Variables: Cardiac Output (CO) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline at Week 24 in Hemodynamic Variables: Total Pulmonary Resistance (TPR) | Baseline (Day 1), Week 24 | |||
| SECONDARY | Change From Baseline at Week 24 in Hemodynamic Variables: Mixed Venous Oxygen Saturation (SvO2) | Baseline (Day 1), Week 24 | |||
| SECONDARY | 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) | Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52 | |||
| SECONDARY | Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama FC | Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fold Change From Baseline at Week 24 in Pulmonary Vascular Resistance Index (PVRI) | Macitentan | 59.43 | Geometric Coefficient of Variation 75.1 | Fold change (percentage) |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan | 7 | |
| Overall Study | COMPLETED | Macitentan | 4 | |
| Overall Study | NOT COMPLETED | Macitentan | 3 |
Source ClinicalTrials.gov
Adverse events37
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Macitentan | 1 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Macitentan | 1 | 7 | |
| other | Conjunctivitis Allergic | Eye disorders | Macitentan | 1 | 7 | |
| other | Ocular Hyperaemia | Eye disorders | Macitentan | 1 | 7 | |
| other | Strabismus | Eye disorders | Macitentan | 1 | 7 | |
| other | Abdominal Pain | Gastrointestinal disorders | Macitentan | 2 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | Macitentan | 1 | 7 | |
| other | Faeces Soft | Gastrointestinal disorders | Macitentan | 1 | 7 | |
| other | Pyrexia | General disorders | Macitentan | 4 | 7 | |
| other | Adenovirus Infection | Infections and infestations | Macitentan | 3 | 7 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan | 0 | 7 |
| Total, other adverse events | Macitentan | 7 | 7 |
| Total, serious adverse events | Macitentan | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05167825
GET https://conductscience.org/api/trials/v1/NCT05167825/registered?page=2