Trial · NCT04780932
Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension
NCT04780932, Phase 2, Phase 3, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension. Trials, record NCT04780932. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04780932
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension
- NCT number
- NCT04780932
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 96 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Thromboembolic Pulmonary Hypertension, Chronic Disease, Inoperable Disease
- Interventions
- Macitentan 10mg, Placebo
- First posted
- 2021-03-04
- Last updated
- 2025-07-20
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on pulmonary vascular resistance (PVR) prior to BPA. | Week 16 | Pulmonary vascular resistance (PVR) at rest at week 16 expressed as a percentage of the baseline resting PVR. |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension prior to BPA | Week 16 | Change from Baseline to Week 16 in 6 Minutes Walk Distance Test |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension prior to BPA | Week 16 | Change from Baseline to Week 16 in World Health Organization Functional Classification |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension prior to BPA | Week 16 | Change from Baseline to Week 16 in Borg dyspnea score |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension prior to BPA | Week 16 | Change from Baseline to Week 16 in NT pro-BNP level |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on quality of life prior to BPA | Week 16 | Change from Baseline to Week 16 in EuroQol-5D-3Level scale |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension after potential BPA | Week 42 | Change from Baseline to Week 42 in 6 Minutes Walk Distance Test |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension after potential BPA | Week 42 | Change from Baseline to Week 42 in World Health Organization Functional Classification |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension after potential BPA | Week 42 | Change from Baseline to Week 42 in Borg dyspnea score |
| Secondary | To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on other clinical measures of pulmonary hypertension after potential BPA | Week 42 | Change from Baseline to Week 42 in NT pro BNP level |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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.
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.
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/NCT04780932
GET https://conductscience.org/api/trials/v1/NCT04780932/registered