Trial Outcomes & Findings for A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging (NCT NCT04435782)
NCT ID: NCT04435782
Last Updated: 2025-03-30
Results Overview
Change from baseline to Week 26 in RVSV assessed by pulmonary artery flow MRI was reported.
TERMINATED
PHASE4
9 participants
Baseline, Week 26
2025-03-30
Participant Flow
Participant milestones
| Measure |
Selexipag
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Selexipag
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Overall Study
Study terminated by sponsor
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4
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Baseline Characteristics
A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
Baseline characteristics by cohort
| Measure |
Selexipag
n=9 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
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Age, Continuous
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42.2 years
STANDARD_DEVIATION 13.28 • n=93 Participants
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Age, Customized
In utero
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0 Participants
n=93 Participants
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Age, Customized
Preterm newborn infants (gestational age < 37 wks)
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0 Participants
n=93 Participants
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Age, Customized
Newborns (0-27 days)
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0 Participants
n=93 Participants
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Age, Customized
Infants and toddlers (28 days-23 months)
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0 Participants
n=93 Participants
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Age, Customized
Children (2-11 years)
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0 Participants
n=93 Participants
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Age, Customized
Adolescents (12-17 years)
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0 Participants
n=93 Participants
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Age, Customized
Adults (18-64 years)
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9 Participants
n=93 Participants
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Age, Customized
From 65-84 years
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0 Participants
n=93 Participants
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Age, Customized
85 years and over
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0 Participants
n=93 Participants
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Sex: Female, Male
Female
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6 Participants
n=93 Participants
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Sex: Female, Male
Male
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3 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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7 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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2 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the statistical analysis plan (SAP), participant wise data was collected and reported due to very limited number of participants enrolled.
Change from baseline to Week 26 in RVSV assessed by pulmonary artery flow MRI was reported.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
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Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Participant 1
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38.35 Milliliter (mL)
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Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Participant 2
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-1.53 Milliliter (mL)
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Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Participant 3
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16.53 Milliliter (mL)
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Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Participant 4
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11 Milliliter (mL)
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Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Participant 5
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27.2 Milliliter (mL)
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Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Participant 6
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14.07 Milliliter (mL)
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
Change from baseline to Week 26 in RVEDV assessed by MRI was reported.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
Participant 1
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40.57 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
Participant 2
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-8.89 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
Participant 3
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23.58 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
Participant 4
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6.79 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
Participant 5
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3.71 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
Participant 6
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7.82 Milliliter
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
Change from baseline to Week 26 in RVESV assessed by MRI was reported.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
Participant 1
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2.23 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
Participant 2
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-7.36 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
Participant 3
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7.05 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
Participant 4
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-4.22 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
Participant 5
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-23.5 Milliliter
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Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
Participant 6
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-6.25 Milliliter
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
Change from baseline to Week 26 in RVEF assessed by MRI was reported. RVEF was the fraction of the end-diastolic volume (EDV) that is ejected out of right ventricle with each contraction. EDV is the volume of blood within a ventricle immediately before a contraction.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
Participant 1
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9.65 Percentage of EDV
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Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
Participant 2
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0.42 Percentage of EDV
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Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
Participant 3
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6.96 Percentage of EDV
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Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
Participant 4
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5.01 Percentage of EDV
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Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
Participant 6
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7.62 Percentage of EDV
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Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
Participant 5
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19.12 Percentage of EDV
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
Change from baseline to Week 26 in RV mass index assessed by MRI was reported.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
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Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
Participant 2
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2.72 Grams per meter square (g/m^2)
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Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
Participant 3
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-12.69 Grams per meter square (g/m^2)
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Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
Participant 4
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0.09 Grams per meter square (g/m^2)
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Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
Participant 5
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-16.56 Grams per meter square (g/m^2)
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Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
Participant 6
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-2.41 Grams per meter square (g/m^2)
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Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
Participant 1
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-11.03 Grams per meter square (g/m^2)
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
Change in RVGLS was a measure of longitudinal percent change in length of endocardium at Week 26 from baseline length assessed by MRI.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
Participant 1: RVGLS Endocardium
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-4.26 Percent change in length of endocardium
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Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
Participant 2: RVGLS Endocardium
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-5.31 Percent change in length of endocardium
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Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
Participant 3: RVGLS Endocardium
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-12.8 Percent change in length of endocardium
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Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
Participant 4: RVGLS Endocardium
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-5.61 Percent change in length of endocardium
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Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
Participant 5: RVGLS Endocardium
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-14.45 Percent change in length of endocardium
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Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
Participant 6: RVGLS Endocardium
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-1.74 Percent change in length of endocardium
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
WHO functional classification for PAH ranged from Class I (no limitation in physical activity, ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope), Class II (slight limitation of physical activity, ordinary physical activity cause undue dyspnea or fatigue, chest pain or near syncope), Class III (marked limitation of physical activity, less than ordinary activity cause undue dyspnea or fatigue, chest pain or near syncope) and Class IV (cannot perform a physical activity without any symptoms, dyspnea and/or fatigue may even be present at rest). Change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". Improvement =reduction in functional class; worsened =increase in functional class; and no change = no change in functional class.
Outcome measures
| Measure |
Selexipag
n=8 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Baseline: Class I
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0 Participants
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Baseline: Class II
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4 Participants
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Baseline: Class III
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4 Participants
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Baseline: Class IV
|
0 Participants
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Week 26: Improved
|
3 Participants
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Week 26: Unchanged
|
5 Participants
|
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Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
Week 26: Worsened
|
0 Participants
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
NT pro-BNP is a cardiac biomarker that is released in the blood in response to changes in the pressure inside of the heart. Levels go up when heart failure develops or gets worse, and levels go down when heart failure is stable or improves. This biomarker helps to measure the changes in the severity of heart failure over time in response to therapy.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Participant 1
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-202.376 nanograms/liter (ng/L)
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Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Participant 2
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142.9233 nanograms/liter (ng/L)
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Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Participant 3
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-261.4904 nanograms/liter (ng/L)
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Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Participant 4
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78.6501 nanograms/liter (ng/L)
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Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Participant 5
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-215.8226 nanograms/liter (ng/L)
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Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Participant 6
|
-762.5677 nanograms/liter (ng/L)
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SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
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Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Participant 1
|
-72 Meter
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Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Participant 2
|
0 Meter
|
|
Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Participant 3
|
275 Meter
|
|
Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Participant 4
|
14 Meter
|
|
Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Participant 5
|
17 Meter
|
|
Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Participant 6
|
16 Meter
|
SECONDARY outcome
Timeframe: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. Any AE occurring at or after the initial administration of study intervention up to 3 days after last dose of study intervention was considered as treatment-emergent.
Outcome measures
| Measure |
Selexipag
n=9 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to last dose of study drug (up to Week 52)Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
Number of participants with AEs leading to premature discontinuation of study drug were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Selexipag
n=9 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to Premature Discontinuation of Study Drug
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
Number of participants with AESI were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESI were anaemia, bleeding events, gastrointestinal disturbances denoting intestinal intussusception (manifested as ileus or obstruction), hyperthyroidism, hypotension, light-dependent non-melanoma skin malignancies, major adverse cardiovascular events (MACE), medication errors, ophthalmological effects associated to retinal vascular system, pregnancy, pulmonary venoocclusive disease associated with pulmonary oedema, renal function impairment / acute renal failure.
Outcome measures
| Measure |
Selexipag
n=9 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
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|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI)
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention.
Number of participants with treatment-emergent marked laboratory abnormalities in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, creatinine, sodium, potassium, hemoglobin, hematocrit; EVF; PCV (male), hematocrit; EVF; PCV (female), platelets (assuming no platelet cluster), leukocytes; white blood cells, Neutrophils (Abs), Eosinophils (Abs), lymphocytes (Abs) were reported. Abnormalities that occurred after study treatment start and up to 3 days after study treatment discontinuation, that were not present at baseline, were treatment-emergent. Treatment-emergent marked laboratory abnormalities were determined at the investigator's discretion.
Outcome measures
| Measure |
Selexipag
n=9 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Number of Participants With Treatment-Emergent Marked Laboratory Abnormalities
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
The risk score is derived for each participant considering the following non-invasive low-risk criteria among the 8 variables: absence of clinical signs of right heart failure, absence of symptoms progression, absence of syncope, WHO FC I-II, 6MWD greater than (\>) 440 meter, NT-proBNP less than (\<) 300 ng/L, Right atrial (RA) area \<18 centimeter square (cm\^2) as determined by echocardiography (Echo), absence of pericardial effusion, as determined by Echo. Number of low-risk criteria at baseline and Week 26 constitutes risk score and were derived for each participant by adding '1' for each of above criteria met. Number of low-risk criteria among the 8 variables for each participant can vary from 0 (worse participants) to 8 (healthier participants). Higher score indicated healthier participants.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
Participant 1
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
Participant 2
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
Participant 3
|
3 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
Participant 4
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
Participant 5
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
Participant 6
|
1 Score on a scale
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Here, "N" (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and "n" (Number Analyzed) signifies participants evaluable for specified rows. As pre-specified in the SAP, participant wise data was collected and reported due to very limited number of participants enrolled.
The risk score is derived for each participant considering the following non-invasive low-risk criteria among the 3 variables: WHO FC I-II, 6MWD \>440 m, NT-proBNP \< 300 ng/L. Number of low-risk criteria at baseline and Week 26 constitutes risk score and were derived for each participant by adding '1' for each of above criteria met. Number of low-risk criteria among the 3 variables for each participant can vary from 0 (worse participants) to 3 (healthier participants). Higher score indicated healthier participants.
Outcome measures
| Measure |
Selexipag
n=6 Participants
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
Participant 1
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
Participant 2
|
0 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
Participant 3
|
2 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
Participant 4
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
Participant 5
|
1 Score on a scale
|
|
Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
Participant 6
|
1 Score on a scale
|
Adverse Events
Selexipag
Serious adverse events
| Measure |
Selexipag
n=9 participants at risk
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Cardiac disorders
Cardiac Failure
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Selexipag
n=9 participants at risk
Participants with pulmonary arterial hypertension (PAH) received a 200 microgram (mcg) selexipag tablet orally on the evening of Day 1, followed by twice-daily dosing starting from Day 2. The dose of selexipag was increased by 200 mcg each week to allow each participant to reach their individual maximum dose (iMD), up to 1600 mcg twice daily, by the end of Week 12. From Week 13 onwards, participants received their iMD of 1600 mcg selexipag tablets orally twice daily until Week 52. Participants were then followed for safety up to 30 days after the last dose of selexipag.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Xerophthalmia
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dental Caries
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.6%
5/9 • Number of events 8 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
77.8%
7/9 • Number of events 8 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 3 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest Pain
|
22.2%
2/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Face Oedema
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Oedema Peripheral
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Covid-19
|
33.3%
3/9 • Number of events 3 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Fungal Skin Infection
|
11.1%
1/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Alanine Aminotransferase Increased
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Body Temperature Increased
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Vitamin D Decreased
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Weight Decreased
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
55.6%
5/9 • Number of events 6 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
44.4%
4/9 • Number of events 4 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness Exertional
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
66.7%
6/9 • Number of events 7 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Paraesthesia
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal Pain
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
22.2%
2/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Flushing
|
22.2%
2/9 • Number of events 2 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hot Flush
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • All Cause Mortality: Day 1 up to 30 days after last dose of drug (up to Week 56), SAEs and non-SAEs: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
Safety analysis set included all participants who received at least 1 dose of study intervention.
|
Additional Information
Study Responsible Scientist
Actelion Pharmaceuticals Ltd
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER