Trial · NCT03496207
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Baseline and 24 weeks | Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks. |
| 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 | Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. |
| 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. | Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24. |
| Primary | Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 32 months | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Primary | Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 30 months | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Secondary | Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks | Baseline and 24 weeks | 6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in basic mobility. |
| Secondary | Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks | Baseline and 24 Weeks | Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks. |
| Secondary | Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks | Baseline and 24 weeks | Each participant's TAPSE, which is commonly used to evaluate tricuspid valve annulus movement as an indicator of right heart function, was measured by echocardiography at baseline and 24 weeks. |
| 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.) | The CAMPHOR is participant-reported questionnaire that contains 65 items in total, 25 relating to symptoms, 25 relating to quality of life (QoL), and 15 relating to activities. Symptom items are scored from 0-25, with a higher score indicating worse symptoms. QoL items are also scored from 0-25, with a higher score indicating a worse QoL and greater functional limitation. Activity items are scored from 0-30, with a higher score indicating poorer functioning. The combined score is obtained by summing up the symptoms score, QoL score and activity score. The lowest combined score possible is 0, while the highest combined score possible is 80. Each participant's CAMPHOR score was recorded at baseline and on Day 1 of Cycle 9. |
| 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.) | The SF-36 questionnaire is a participant-reported survey of a participant's health. The survey evaluates 8 aspects of functional health and well-being that relate to either physical health or mental health. The physical component summary is based primarily on physical functioning, bodily pain, and general health. The mental component summary encompasses vitality, social functioning, and emotional and mental health. Total scores for the physical component range from 0-100, with 100 representing the highest level of physical functioning. The total scores for the mental component also range from 0-100, with 100 representing the highest level of mental functioning. Each participant's SF-36 was recorded at baseline and on Day 1 of Cycle 9. Each cycle was 21 days. |
| Secondary | Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH) | Up to 24 weeks | Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD). |
| 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 | The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. |
| Secondary | Base Study: Number of Participants Who Experienced One or More AEs | Up to 24 weeks | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Secondary | Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 24 weeks | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| 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.) | Each participant's BMI was measured at baseline and at 24 weeks. |
| 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.) | Each participant's systolic and diastolic blood pressure was taken at baseline and on Day 1 of Cycle 9. Each cycle was 21 days. |
| 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.) | Each participant's respiratory rate (number of breaths per minute) was measured at baseline and on Day 1 of Cycle 9. Each cycle was 21 days. |
| 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.) | Each participant's QTcF Interval was measured at baseline and on Day 1 of Cycle 9. |
| Secondary | Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept | Day 8 of Cycle 1 (Each cycle was 21 days.) | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Based on population pharmacokinetic (PopPK) modeling of previous sotatercept studies, Cmax occurs at Day 8 of Cycle 1 after a sotatercept dose is given. The sotatercept concentration at Day 8 of Cycle 1 (each cycle was 21 days) is presented here as Cmax. |
| 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 | 6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third RCH was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility. |
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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