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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03496207
Registration number
NCT03496207
Ethics application status
Date submitted
29/03/2018
Date registered
12/04/2018
Date last updated
19/04/2023
Titles & IDs
Public title
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
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Scientific title
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
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Secondary ID [1]
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2017-004738-27
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Secondary ID [2]
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A011-09
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Universal Trial Number (UTN)
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Trial acronym
PULSAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Sotatercept
Other interventions - SOC
Placebo Comparator: Placebo - Participants will receive placebo plus SOC by SC injection during the 24-week treatment period. Dosing will occur once every 3 weeks.
Experimental: Sotatercept 0.3 mg/kg - Participants will receive sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period. Per protocol, participants may have their doses titrated. Dosing will occur once every 3 weeks.
Experimental: Sotatercept 0.7 mg/kg - Participants will receive sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period. Per protocol, participants may have their doses titrated. Dosing will occur once every 3 weeks.
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: Sotatercept
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Other interventions: SOC
SOC therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with endothelin-receptor antagonists, phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks
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Assessment method [1]
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Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.
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Timepoint [1]
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Baseline and 24 weeks
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Primary outcome [2]
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Extension Period: Change From Baseline in PVR (Delayed-Start Analysis)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
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Primary outcome [3]
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Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
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Primary outcome [4]
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Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 32 months
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Primary outcome [5]
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Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 30 months
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Secondary outcome [1]
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Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 24 weeks
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Secondary outcome [2]
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Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 24 Weeks
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Secondary outcome [3]
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Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and 24 weeks
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Secondary outcome [4]
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Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
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Secondary outcome [5]
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Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
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Secondary outcome [6]
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Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
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Assessment method [6]
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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).
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Timepoint [6]
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Up to 24 weeks
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Secondary outcome [7]
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Base Study: Number of Participants Who Experienced an Improvement From Baseline in World Health Organization (WHO) Functional Class at 24 Weeks
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and 24 Weeks
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Secondary outcome [8]
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Base Study: Number of Participants Who Experienced One or More AEs
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 24 weeks
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Secondary outcome [9]
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Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 24 weeks
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Secondary outcome [10]
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Base Study: Change From Baseline in Body Mass Index (BMI) at Cycle 9
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Assessment method [10]
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Each participant's BMI was measured at baseline and at 24 weeks.
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Timepoint [10]
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Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
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Secondary outcome [11]
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Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9
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Assessment method [11]
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Each participant's systolic and diastolic blood pressure was taken at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
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Timepoint [11]
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Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
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Secondary outcome [12]
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Base Study: Change From Baseline in Respiratory Rate at Cycle 9
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
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Secondary outcome [13]
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Base Study: Change From Baseline in QTcF Interval at Cycle 9
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Assessment method [13]
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Each participant's QTcF Interval was measured at baseline and on Day 1 of Cycle 9.
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Timepoint [13]
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Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
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Secondary outcome [14]
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Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept
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Assessment method [14]
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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.
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Timepoint [14]
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Day 8 of Cycle 1 (Each cycle was 21 days.)
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Secondary outcome [15]
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Extension Period: Change From Baseline in 6MWD (Delayed-Start Analysis)
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
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Secondary outcome [16]
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Extension Period: Change From Baseline in 6MWD (Placebo-Crossed Analysis)
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Assessment method [16]
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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 right heart catheterization 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.
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Timepoint [16]
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Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
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Secondary outcome [17]
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Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)
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Assessment method [17]
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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. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
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Timepoint [17]
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Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
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Secondary outcome [18]
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Extension Period: Change From Baseline in WHO Functional Class (Placebo-Crossed Analysis)
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Assessment method [18]
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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. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
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Timepoint [18]
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Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
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Eligibility
Key inclusion criteria
1. Age =18 years
2. Documented diagnostic right heart catheterization (RHC) at any time prior to Screening
confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH in any of
the following subtypes:
i. Idiopathic ii. Heritable PAH iii. Drug- or toxin-induced PAH iv. PAH associated
with connective tissue disease v. PAH associated with simple, congenital
systemic-to-pulmonary shunts at least 1 year following shunt repair
3. Symptomatic pulmonary hypertension classified as WHO functional class II or III
4. Screening RHC documenting a minimum PVR of =400 dyn·sec/cm5 (5 Wood units)
5. Pulmonary function tests (PFTs) within 6 months prior to Screening as follows:
1. Total lung capacity (TLC) >70% predicted; or if between 60 to 70% predicted, or
not possible to be determined, confirmatory high-resolution computed tomography
(CT) indicating no more than mild interstitial lung disease (ILD), per
investigator interpretation, or
2. Forced expiratory volume (first second) (FEV1)/ forced vital capacity (FVC) >70%
predicted
6. Ventilation-perfusion (VQ) scan (or, if unavailable a negative CT pulmonary angiogram
[CTPA] result, or pulmonary angiography result), any time prior to Screening Visit or
conducted during the Screening Period, with normal or low probability result),
7. No contraindication per investigator for RHC during the study
8. 6MWD =150 and =550 meters repeated twice at Screening and both values within 15% of
each other, calculated from the highest value
9. PAH therapy at stable (per investigator) dose levels of SOC therapies
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g,
diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to study visit Cycle
1 Day 1 (C1D1)
2. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine,
vasopressin) within 30 days prior to study visit C1D1
3. History of atrial septostomy within 180 days prior to Screening
4. History of more than mild obstructive sleep apnea that is untreated
5. Known history of portal hypertension or chronic liver disease, including hepatitis B
and/or hepatitis C (with evidence of recent infection and/or active virus
replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
6. History of human immunodeficiency virus infection-associated PAH
7. Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536)
8. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days
prior to C1D1 or planned initiation during the study (participants who are stable in
the maintenance phase of a program and who will continue for the duration of the study
are eligible).
9. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
(BP) >160 mm Hg or sitting diastolic blood pressure >100 mm Hg during Screening Visit
after a period of rest
10. Systolic BP <90 mmHg during Screening or at baseline
11. History of known pericardial constriction
12. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) >480 msec
during Screening Period or C1D1
13. Personal or family history of long QTc syndrome or sudden cardiac death
14. Cerebrovascular accident within 3 months of C1D1
15. History of restrictive or congestive cardiomyopathy
16. Left ventricular ejection fraction (LVEF) <45% on historical echocardiogram (ECHO)
within 6 months prior to Screening Period (or done as a part of the Screening Period)
or pulmonary capillary wedge pressure (PCWP) >15 mmHg as determined in the Screening
Period RHC.
17. Any current or prior history of symptomatic coronary disease (prior myocardial
infarction, percutaneous coronary intervention, coronary artery bypass graft surgery,
or cardiac anginal chest pain)
18. Acutely decompensated heart failure within 30 days prior to study visit C1D1, as per
investigator assessment
19. Significant (=2+ regurgitation) mitral regurgitation (MR) or aortic regurgitation (AR)
valvular disease
20. Any of the following clinical laboratory values during the Screening Period prior to
C1D1:
1. Baseline Hgb >16.0 g/dL
2. Serum alanine aminotransferase or aspartate aminotransferase levels >3X upper
limit of normal (ULN) or total bilirubin >1.5X ULN within 28 days of C1D1
3. Estimated glomerular filtration rate <30 ml/min/1.73m2 (4-variable Modification
of Diet in Renal Disease equation) within 28 days of C1D1 or required renal
replacement therapy within 90 days
4. WBC count <4000/mm3
5. Platelets <100,000/µL
6. Absolute neutrophil count <1500/mm3
21. History of opportunistic infection (e.g., invasive candidiasis or pneumocystis
pneumonia) within 6 months prior to Screening; serious local infection (e.g.,
cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to
Screening
22. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant
proteins or excipients in the investigational product
23. Major surgery within 8 weeks prior to C1D1. Participants must have completely
recovered from any previous surgery prior to C1D1.
24. Prior heart or heart-lung transplants or life expectancy of <12 month
25. Pregnant or breastfeeding females
26. If on corticosteroids, and at any time in the last 30 days prior to the Screening
Period: have been receiving doses of >20 mg/day of prednisone (or equivalent) or on a
new or changing dose of =20 mg/day; only participants receiving stable doses of =20 mg
prednisone (or equivalent) in last 30 days prior to the Screening Period permitted in
the study
27. History of active malignancy, with the exception of fully excised or treated basal
cell carcinoma, cervical carcinoma in-situ, or =2 squamous cell carcinomas of the skin
28. History of clinically significant (as determined by the investigator) non-PAH related
cardiac, endocrine, hematologic, hepatic, (auto)immune, metabolic, urologic,
pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another
disease that may limit participation in the study. Autoimmune diseases are excluded
with the exception of those related to PAH etiologies included in this study.
29. Participation in another clinical trial involving intervention with another
investigational drug, approved therapy for investigational use, or investigational
device within 4 weeks prior to C1D1, or if the half-life of the previous product is
known, within 5 times the half-life prior to C1D1, whichever is longer
30. Weight >140 kg at Screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/03/2022
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
NSW,New South WhalesQLD
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Recruitment hospital [1]
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St. Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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John Hunter Hospital - New Lambton
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Recruitment hospital [4]
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Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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2305 - New Lambton
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
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0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kansas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Michigan
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Ohio
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Country [8]
0
0
United States of America
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State/province [8]
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0
South Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Texas
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Country [10]
0
0
Brazil
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State/province [10]
0
0
Minas Gerais
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Country [11]
0
0
Brazil
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State/province [11]
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0
Riogrande Do Sul
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Country [12]
0
0
Brazil
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State/province [12]
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0
Santa Catarina
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Country [13]
0
0
Brazil
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State/province [13]
0
0
Cerqueira César
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Jardim Botânico
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Sao Paulo
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Country [16]
0
0
France
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State/province [16]
0
0
Hérault
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Country [17]
0
0
France
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State/province [17]
0
0
La Tronche
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Country [18]
0
0
France
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State/province [18]
0
0
Le Kremlin-Bicêtre
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Country [19]
0
0
France
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State/province [19]
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0
Saint-Étienne
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Country [20]
0
0
Germany
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State/province [20]
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0
Niedersachsen
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Country [21]
0
0
Germany
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State/province [21]
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0
Sachsen-Anhalt
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Country [22]
0
0
Germany
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State/province [22]
0
0
Sachsen
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Country [23]
0
0
Germany
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State/province [23]
0
0
Dresden
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Country [24]
0
0
Israel
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State/province [24]
0
0
Ashkelon
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Country [25]
0
0
Israel
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State/province [25]
0
0
Haifa
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Country [26]
0
0
Israel
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State/province [26]
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Kefar Sava
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Country [27]
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Israel
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Petach-Tikva
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Israel
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Ramat Gan
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Spain
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Cantabria
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Spain
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Madrid
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Spain
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Barcelona
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United Kingdom
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Clydebank
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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Ethics approval
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Summary
Brief summary
Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011)
relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible
participants will receive study treatment for 24 weeks during the placebo-controlled
treatment period, and then will be eligible to enroll into a 30-month extension period during
which all participants will receive sotatercept. All treated patients will also undergo a
follow-up period after last study drug treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03496207
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03496207
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