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Trial · NCT05167825

Outcomes45

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYFold Change From Baseline at Week 24 in Pulmonary Vascular Resistance Index (PVRI)Baseline (Day 1), Week 24Efficacy analysis set included all participants who were administered at least 1 dose of macitentan.Fold change (percentage)GEOMETRIC_MEAN
SECONDARYChange From Baseline at Week 24 in Hemodynamic Variables: Pulmonary Vascular Resistance (PVR)Baseline (Day 1), Week 24
SECONDARYChange From Baseline in Mean Right Atrial Pressure (mRAP)Baseline (Day 1), Week 24
SECONDARYChange From Baseline at Week 24 in Hemodynamic Variables: Mean Pulmonary Arterial Pressure (mPAP)Baseline (Day 1), Week 24
SECONDARYChange From Baseline at Week 24 in Hemodynamic Variables: Cardiac Index (CI)Baseline (Day 1), Week 24
SECONDARYChange From Baseline at Week 24 in Hemodynamic Variables: Cardiac Output (CO)Baseline (Day 1), Week 24
SECONDARYChange From Baseline at Week 24 in Hemodynamic Variables: Total Pulmonary Resistance (TPR)Baseline (Day 1), Week 24
SECONDARYChange From Baseline at Week 24 in Hemodynamic Variables: Mixed Venous Oxygen Saturation (SvO2)Baseline (Day 1), Week 24
SECONDARYNumber 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
SECONDARYNumber of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama FCWeeks 4, 8, 12, 16, 20, 24, 28, 40, 52
SECONDARYChange From Baseline to Weeks 24 and 52 in 6-minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT)Baseline (Day 1), Weeks 24 and 52
SECONDARYChange From Baseline to Week 12, 24, 28, 40, and 52 in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)Baseline (Day 1), Week 12, 24, 28, 40, and 52
SECONDARYChange From Baseline at Weeks 12, 24, and 52 in Tricuspid Annular Plane Systolic Excursion (TAPSE)Baseline (Day 1), Weeks 12, 24, and 52
SECONDARYChange From Baseline at Week 12, 24, and 52 in Left Ventricular Eccentricity Index (LVEI)Baseline (Day 1), Weeks 12, 24 and 52
SECONDARYChange From Baseline to Week 12, 24, and 52 in Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales Short Form (SF-15)Baseline (Day 1), Weeks 12, 24, and 52
SECONDARYChange From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Number of Hours of Daytime ActivityBaseline (Day 1), Weeks 12, 24, and 52
SECONDARYChange From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Count Per Minute of Daily ActivityBaseline (Day 1), Weeks 12, 24, and 52
SECONDARYChange From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Light Physical ActivityBaseline (Day 1), Weeks 12, 24, and 52
SECONDARYChange From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Moderate to Vigorous Physical ActivityBaseline (Day 1), Weeks 12, 24, and 52
SECONDARYChange From Baseline to Week 24 and Week 52 in Borg Dyspnea IndexBaseline (Day 1), Weeks 24 and 52

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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