Trial · NCT03738150
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at End Of Treatment (EOT), with no major protocol deviations. | mL/min/kg | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL | MEAN |
| SECONDARY | Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks | Baseline and 24 Weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | Percent change | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | mL/m^2 | MEAN |
| SECONDARY | Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | grams | MEAN |
| SECONDARY | Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | Unitless | MEAN |
| SECONDARY | Change From Baseline in Cardiac Index at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in Cardiac Index at 24 Weeks. | Liter/min/m^2 | MEAN |
| SECONDARY | Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Arteriovenous O2 Content Difference (Ca-vO2) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in Ca-vO2 at 24 Weeks. | mL/100 mL | MEAN |
| SECONDARY | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in PVR at 24 Weeks. | dynes*sec/cm^5 | MEAN |
| SECONDARY | Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks | Baseline and 24 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Change from Baseline in 6MWD at 24 Weeks. | meters | MEAN |
| SECONDARY | Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks | Baseline and 24 Weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and had data for Change from Baseline in Concentration of NT-proBNP at 24 Weeks. | pg/mL | MEAN |
| SECONDARY | Change From Baseline in WHO (World Health Organization) Functional Class at 24 Weeks | Baseline and 24 Weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations. | WHO functional class | MEAN |
| SECONDARY | Number of Participants With One or More Adverse Events (AEs) | Up to 24 weeks | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced One or More Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH) | Up to 102 weeks | All participants who completed treatment period, had iCPET assessment and cardiac MRI at 24 weeks or ended treatment early and had iCPET assessment and cardiac MRI at EOT, with no major protocol deviations; and who had data for Number of Participants Who Experienced One or More Events Indicative of Clinical Worsening of PAH. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Observed Trough Concentration (Ctrough) of Sotatercept at Cycle 9 | Day 1 of Cycle 9 (Each cycle was 21 days.) | All participants who received at least 1 dose of study treatment, had at least 1 blood sample analyzed for PK, had data for Observed Ctrough of Sotatercept at Cycle 9, and followed the dosing regimen. | ng/mL | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Sotatercept at Cycle 9 | Day 1 of each 21-day cycle: Cycles 1-9 | All participants who received at least 1 dose of study treatment and had at least 1 blood sample analyzed for PK, had data for Cmax of Sotatercept at Cycle 9, and followed the dosing regimen. | ng/mL | MEAN |
| SECONDARY | Minimum Plasma Concentration (Cmin) of Sotatercept at Cycle 9 | Day 1 of each 21-day cycle: Cycles 1-9 | All participants who received at least 1 dose of study treatment, had at least 1 blood sample analyzed for PK, had data for Cmin of Sotatercept at Cycle 9, and followed the dosing regimen. | ng/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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