Trial · NCT02932410
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
NCT02932410, Phase 3, Completed, Actelion; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH). Trials, record NCT02932410. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02932410
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT02932410
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 165 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan, Standard-of-care
- First posted
- 2016-10-13
- Last updated
- 2026-03-13
- Results first posted
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Pre-dose at Week 12 | Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 12 based on body weight were reported. This outcome measure was planned to be analyzed for specified arms only. |
| Primary | Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group | Pre-dose at Week 12 | Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 12 based on age group were reported. This outcome measure was planned to be analyzed for specified arms only. |
| Primary | Participants <2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 4 | Pre-dose at Week 4 | Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 4 were reported. This outcome measure was planned to be analyzed for specified arms only. |
| Primary | Participants From China With >=12 to <18 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 | Pre-dose at Week 12 | Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 12 were reported. |
| Secondary | Time to the First Clinical Event Committee (CEC)-Confirmed Disease Progression Event | Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) | |
| Secondary | Time to First CEC-confirmed Hospitalization for PAH | Baseline (Day 1) up to EOCP (up to 7.08 years) | |
| Secondary | Time to CEC-confirmed Death Due to PAH | Baseline (Day 1) up to EOCP (up to 7.08 years) | |
| Secondary | Time to Death (All Causes) | Baseline (Day 1) up to 7.26 years | |
| Secondary | Percentage of Participants With World Health Organization (WHO) Functional Class (FC) I or II Versus III or IV | At Weeks 12 and 24 | |
| Secondary | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Weeks 12 and 24 | Baseline (Day 1), Weeks 12 and 24 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Pre-dose at Week 12 | The Pharmacokinetics (PK) 1 set included all participants aged \>=2 years randomized to and treated with macitentan, for whom a PK blood sample at trough had been taken and who did not deviate from the protocol in a way that affected the evaluation of the PK trough endpoints. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number analyzed) signifies number of participants analyzed for specified categories. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group | Pre-dose at Week 12 | The Pharmacokinetics (PK) 1 set included all participants aged \>=2 years randomized to and treated with macitentan, for whom a PK blood sample at trough had been taken and who did not deviate from the protocol in a way that affected the evaluation of the PK trough endpoints. Here N (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and n(number analyzed) signifies number of participants analyzed for specified categories. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Participants <2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 4 | Pre-dose at Week 4 | PK Set 3 included all participants aged \<2 years and treated with macitentan for whom a PK blood sample had been taken and who did not deviate from the protocol in a way that might affect the evaluation of the PK endpoints. | ng/mL | MEAN |
| PRIMARY | Participants From China With >=12 to <18 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 | Pre-dose at Week 12 | PK Analysis Set China (PK CHN) included all participants \>=12 years to \<18 years who were treated with macitentan, for whom a PK blood sample has been taken and who did not deviate from the protocol in a way that might affect the evaluation of the PK endpoints. | ng/mL | MEAN |
| SECONDARY | Time to the First Clinical Event Committee (CEC)-Confirmed Disease Progression Event | Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) | |||
| SECONDARY | Time to First CEC-confirmed Hospitalization for PAH | Baseline (Day 1) up to EOCP (up to 7.08 years) | |||
| SECONDARY | Time to CEC-confirmed Death Due to PAH | Baseline (Day 1) up to EOCP (up to 7.08 years) | |||
| SECONDARY | Time to Death (All Causes) | Baseline (Day 1) up to 7.26 years | |||
| SECONDARY | Percentage of Participants With World Health Organization (WHO) Functional Class (FC) I or II Versus III or IV | At Weeks 12 and 24 | |||
| SECONDARY | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Weeks 12 and 24 | Baseline (Day 1), Weeks 12 and 24 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Macitentan: >=10 kg and <15 kg | 150.133 | Standard Deviation 67.5742 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Macitentan: >=15 kg and <25 kg | 153.892 | Standard Deviation 108.3185 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Macitentan: >=25 kg and <50 kg | 200.975 | Standard Deviation 151.6511 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Macitentan: >=50 kg | 208.067 | Standard Deviation 92.4246 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Aprocitentan: >=10 kg to <15 kg | 1165.000 | Standard Deviation 390.7628 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Aprocitentan: >=15 kg and <25 kg | 859.333 | Standard Deviation 217.2926 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Aprocitentan: >=25 kg and <50 kg | 980.857 | Standard Deviation 391.3308 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight | Macitentan (JNJ-67896062) (>=2 Years) | Aprocitentan: >=50 kg | 1011.267 | Standard Deviation 288.3632 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group | Macitentan (JNJ-67896062) (>=2 Years) | Macitentan: >=2 to <6 years | 159.767 | Standard Deviation 84.5424 | nanograms per milliliter (ng/mL) |
| Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group | Macitentan (JNJ-67896062) (>=2 Years) | Macitentan: >=6 to <12 years | 184.792 | Standard Deviation 148.2530 | nanograms per milliliter (ng/mL) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macitentan (JNJ-67896062) (>=2 Years) | 73 | |
| Overall Study | STARTED | Standard of Care (SoC; >=2 Years) | 75 | |
| Overall Study | STARTED | Macitentan (JNJ-67896062) (<2 Years) | 9 | |
| Overall Study | STARTED | China Single-arm Cohort (>=12 to <18 Years) | 8 | |
| Overall Study | Treated | Macitentan (JNJ-67896062) (>=2 Years) | 72 | |
| Overall Study | Treated | Standard of Care (SoC; >=2 Years) | 75 | |
| Overall Study | Treated | Macitentan (JNJ-67896062) (<2 Years) | 9 | |
| Overall Study | Treated | China Single-arm Cohort (>=12 to <18 Years) | 8 | |
| Overall Study | Crossed Over to Macitentan Treatment | Macitentan (JNJ-67896062) (>=2 Years) | 0 | |
| Overall Study | Crossed Over to Macitentan Treatment | Standard of Care (SoC; >=2 Years) | 8 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events620
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 | Anaemia | Blood and lymphatic system disorders | Macitentan (JNJ-67896062) (>=2 Years) | 6 | 72 | |
| other | Anaemia | Blood and lymphatic system disorders | Macitentan (JNJ67896062) (<2 Years) | 0 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SoC; >=2 Years) | 3 | 75 | |
| other | Anaemia | Blood and lymphatic system disorders | SOC (>=2 Years) Crossover to Macitentan | 1 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | China Single-arm Cohort (>=12 to <18 Years) | 0 | 8 | |
| other | Abdominal Pain | Gastrointestinal disorders | Macitentan (JNJ-67896062) (>=2 Years) | 4 | 72 | |
| other | Abdominal Pain | Gastrointestinal disorders | Macitentan (JNJ67896062) (<2 Years) | 0 | 9 | |
| other | Abdominal Pain | Gastrointestinal disorders | Standard of Care (SoC; >=2 Years) | 6 | 75 | |
| other | Abdominal Pain | Gastrointestinal disorders | SOC (>=2 Years) Crossover to Macitentan | 0 | 8 | |
| other | Abdominal Pain | Gastrointestinal disorders | China Single-arm Cohort (>=12 to <18 Years) | 0 | 8 |
1 to 10 of 620Source ClinicalTrials.gov
See all 620 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macitentan (JNJ-67896062) (>=2 Years) | 7 | 73 |
| Total, all-cause mortality | Macitentan (JNJ67896062) (<2 Years) | 0 | 9 |
| Total, all-cause mortality | Standard of Care (SoC; >=2 Years) | 6 | 75 |
| Total, all-cause mortality | SOC (>=2 Years) Crossover to Macitentan | 0 | 8 |
| Total, all-cause mortality | China Single-arm Cohort (>=12 to <18 Years) | 0 | 8 |
| Total, other adverse events | Macitentan (JNJ-67896062) (>=2 Years) | 60 | 72 |
| Total, other adverse events | Macitentan (JNJ67896062) (<2 Years) | 6 | 9 |
| Total, other adverse events | Standard of Care (SoC; >=2 Years) | 44 | 75 |
| Total, other adverse events | SOC (>=2 Years) Crossover to Macitentan | 5 | 8 |
| Total, other adverse events | China Single-arm Cohort (>=12 to <18 Years) | 6 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41796854 | DERIVED |
Source PubMed
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/NCT02932410
GET https://conductscience.org/api/trials/v1/NCT02932410/registered?page=2