Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

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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
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 after potential BPA	Week 42	Change from Baseline to Week 42 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 Pulmonary vascular resistance after potential BPA	Week 42	Change from baseline to week 42 in PVR and percentage of subjects reaching PVR\<240 dyn.sec.cm-5 at week 42.
Secondary	To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on the rate of BPA procedure-related complications	Immediately after intervention	Frequency and type of BPA procedure-related complications from BPA procedure to end-of-study
Secondary	To compare the effect of an initial dual oral treatment (riociguat, macitentan) vs. standard-of-care initial oral monotherapy (riociguat, placebo) on the disease progression	Week 42	Time from randomization to the first PH-related disease progression event up to end-of-study, defined as any of the following : Death (all causes), Need for lung transplantation, Hospitalization due to PH, Initiation of parenteral prostanoid therapy due to PH-related disease progression , Worsening defined as a post-baseline decrease in 6MWD by ≥ 15 % combined with WHO FC III or IV).
Secondary	Recording of serious and non serious adverse events/effects, Treatment-emergent adverse events (AEs) and serious adverse events (SAEs), AEs leading to premature discontinuation of study drug	Week 42
Secondary	Change from baseline in laboratory variable, weight and vital signs o Change from baseline in laboratory variables o Change from baseline in weight and vital signs (arterial blood pressure, heart rate).	Week 42

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

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.

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