Trial · NCT03496207
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Baseline and 24 weeks | All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and End of Treatment (EOT) assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | dynes*sec/cm^5 | MEAN |
| PRIMARY | Extension Period: Change From Baseline in PVR (Delayed-Start Analysis) | Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24 | All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints | dynes*sec/cm^5 | MEAN |
| PRIMARY | Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis) | Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. | All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints | dynes*sec/cm^5 | MEAN |
| PRIMARY | Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 32 months | All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 30 months | All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks | Baseline and 24 weeks | All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | meters | LEAST_SQUARES_MEAN |
| SECONDARY | Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks | Baseline and 24 Weeks | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | pg/mL | MEAN |
| SECONDARY | Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks | Baseline and 24 weeks | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | cm | MEAN |
| SECONDARY | Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | Score on a scale | MEAN |
| SECONDARY | Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH) | Up to 24 weeks | All randomized participants who received their assigned treatment and had data for Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of PAH | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Base Study: Number of Participants Who Experienced an Improvement From Baseline in World Health Organization (WHO) Functional Class at 24 Weeks | Baseline and 24 Weeks | All randomized participants who received their assigned treatment and at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for Base Study: Number of Participants Who Experienced an Improvement from Baseline in WHO Functional Class at 24 Weeks. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose to which originally assigned. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Base Study: Number of Participants Who Experienced One or More AEs | Up to 24 weeks | All randomized participants who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 24 weeks | All randomized participants who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Base Study: Change From Baseline in Body Mass Index (BMI) at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in BMI at Cycle 9 | kg/m^2 | MEAN |
| SECONDARY | Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in Systolic and Diastolic Blood Pressure at Cycle 9 | mmHg | MEAN |
| SECONDARY | Base Study: Change From Baseline in Respiratory Rate at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in Respiratory Rate at Cycle 9 | breaths/min | MEAN |
| SECONDARY | Base Study: Change From Baseline in QTcF Interval at Cycle 9 | Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.) | All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in QTcF Interval at Cycle 9 | milliseconds | MEAN |
| SECONDARY | Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept | Day 8 of Cycle 1 (Each cycle was 21 days.) | All randomized participants who received at least 1 dose of sotatercept and had sufficient pharmacokinetic samples collected and assayed for PK analysis | ng/mL | MEAN |
| SECONDARY | Extension Period: Change From Baseline in 6MWD (Delayed-Start Analysis) | Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24 | All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in 6MWD (Delayed-Start Analysis) | meters | LEAST_SQUARES_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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GET https://conductscience.org/api/trials/v1/NCT03496207/outcomes