Trial · NCT04567602
A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag
NCT04567602, Completed, Janssen-Cilag S.p.A.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag. Trials, record NCT04567602. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04567602
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag
- NCT number
- NCT04567602
- Status
- Completed
- Enrollment
- 372 participants, actual
- Lead sponsor
- Janssen-Cilag S.p.A.
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- PAH medication
- First posted
- 2020-09-28
- Last updated
- 2025-06-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months | Baseline and 12 Months | Change from baseline in the number of the non-invasive low-risk criteria will be assessed according to the following parameters: world health organization (WHO)/functional class (FC)- I, II, 6-minute walk distance (6MWD) greater than (\>) 440 meters (m), and brain natriuretic peptide (BNP) less than (\<) 50 nanogram per liter (ng/l) or N-terminal-pro-hormone brain natriuretic Peptide (NT-proBNP) \<300 ng/l. |
| Secondary | Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months | Baseline up to 12 and 24 Months | Risk profile is assessed as improved, stable or worsened where improved indicates 1 or more non-invasive parameters from intermediate to low risk profile; stable indicates no change in the parameters; and worsened indicates 1 or more non-invasive parameters move from low or intermediate to intermediate or high range risk. |
| Secondary | Change in Progression in the Number of Participants with Low/High Intermediate Risk | Baseline up to 24 Months | Change in risk profile for the low/high intermediate risk participants according to following cut-off values for low intermediate risk/high intermediate risk, respectively: (6MWD \[greater than or equal to \[\>=\] or \< 300m\], Peak oxygen consumption \[VO2\] \[\>= or \< 50% predicted\], BNP \[less than or equal to \[\<=\] or \> 175 ng/l\], or NT-proBNP \[\<= or \> 850 ng/l\], right atrial area \[RA\] \[\<= or \> 22 centimeter \[cm\]\] and right atrial pressure \[RAP\] \[\<= or \> 11 millimeter of mercury \[mmHg\]\] or stroke volume index (SVI) (\> or \<= 38 milliliter per meter square \[ml/m2\])). The low intermediate risk is defined by a presence of at least three low intermediate parameters and a high intermediate risk is defined by a presence of at least three high intermediate parameters. |
| Secondary | Change from Baseline in 6MWD | Baseline up to 24 Months | Change from baseline in 6MWD will be reported. |
| Secondary | Change from Baseline in BNP or NT-proBNP | Baseline up to 24 Months | Change from baseline in BNP or NT-proBNP will be reported. |
| Secondary | Change from Baseline in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) 2.0 Risk Score up to 12 and 24 Months | Baseline up to 12 and 24 Months | The REVEAL risk calculator determines the risk status and the scores can be defined as: low risk as a score of \<= 6, intermediate risk as a score of 7 or 8, and high risk as a score of \>= 9 for the survival rates. |
| Secondary | Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH) | Up to 24 Months | Adherence to ESC/ERS guidelines and 6th WSPH will be reported. |
| Secondary | Change from Baseline in Echocardiographic Parameters | Baseline up to 24 Months | Change in echocardiographic parameters will be reported as assessed by echocardiogram. |
| Secondary | Change from Baseline in Hemodynamic Parameters | Baseline up to 24 Months | Change in hemodynamic parameters will be reported. |
| Secondary | Hospitalization Rate due to Worsening of PAH | Up to 24 Months | The hospitalization rate due to PAH worsening will be calculated based on the number of participants with at least one hospitalization. The calculation of the rate will be based on the number of events over the whole follow-up time that is exposure time. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41956554 | 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04567602
GET https://conductscience.org/api/trials/v1/NCT04567602/registered