| Primary | Percentage of Subjects With Sustained Treatment Transition | A sustained treatment transition is considered if the 3 following criteria are met a) being on study treatment (selexipag) at Week 16, and b) not having a study treatment interruption(s) of a total of 8 days or more prior to Week 16, and c) absence of inhaled treprostinil or any prostanoid treatment after Week 8 up to Week 16. The percentage of subjects with a sustained treatment transition is calculated with 95% confidence interval (CI) using the Clopper-Pearson method. | All subjects who took at least one dose of selexipag were included in the safety analyses | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Primary | Percentage of Subjects With Treatment-emergent Adverse Events (AEs), | Percentage of subjects with treatment-emergent AEs (serious and non serious), regardless of relationship to selexipag | All subjects who took at least one dose of selexipag were included in the safety analyses | Posted | | Number | | Percentage of participants | | 26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag) | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Primary | Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag | Number of subjects with adverse events leading to premature discontinuation of selexipag is determined from the first dose of selexipag up to the last dose of selexipag | All subjects who took at least one dose of selexipag were included in the safety analyses | Posted | | Count of Participants | | Participants | | Up to 22 weeks on average | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Primary | Absolute Change From Baseline Over Time in Blood Pressure | Both systolic(SBP) and diastolic (DBP) arterial blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. Median change from baseline to pre-specified post-baseline visits are calculated | All subjects who took at least one dose of selexipag were included in the safety analyses | Posted | | Median | Full Range | mmHg | | Baseline, Week 4, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Primary | Absolute Change From Baseline Over Time in Heart Rate (HR) | Pulse rate is measured after at least 5 minutes of rest in a sitting position. Median change from baseline to pre-specified post-baseline visits are calculated. | All subjects who took at least one dose of selexipag were included in the safety analyses | Posted | | Median | Full Range | beats per minute (bpm) | | Baseline, Week 4, Week 12, Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Primary | Maximal Tolerated Dose | This is the individual maximal tolerated dose (MTD) observed at Week 12 in the subjects still on selexipag at Week 16. MTD is defined as the dose of selexipag reached with the last dose change up to Week 12 | Sensitivity analysis: only patients being on selexipag at week 16 are considered. | Posted | | Median | Full Range | mcg | | At Week 12, in subjects still on selexipag at Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Primary | Time to Discontinuation of Inhaled Treprostinil. | Median time from baseline (Day1) to the end of down-titration of inhaled treprostinil is calculated | All subjects who took at least one dose of selexipag were included in the safety analyses | Posted | | Median | Full Range | weeks | | Baseline to Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Secondary | Percentage of Subjects With WHO Functional Class (FC) Change From Baseline | The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension: Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class III (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms. Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined. | | Posted | | Number | | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Secondary | Absolute Change in 6-minute Walk Distance (6MWD) at Trough | The 6MWT is a non-encouraged test, which measures the distance (in meters) covered by the subject during a 6-minute walk. It is performed in a 30-meters long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Absolute change from baseline to Week 16 in 6MWD is measured at trough levels of inhaled treprostinil and/or selexipag. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWT at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWT at Visit 5 (Week 16). | | Posted | | Median | 95% Confidence Interval | meters | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Secondary | Percentage of Patients With Change in 6-minute Walk Distance (6MWD) | Percentage of patients with an increase (> 8% of baseline), maintenance (+/- 8% of baseline), or decrease (< -8% of baseline) in their 6MWD (at trough) from baseline to Week 16. The ± 8% boundaries for change in 6MWD reflect the approximately 8% coefficient of variation in the reproducibility of the 6MWD. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWD test at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWD test at Visit 5 (Week 16). | | Posted | | Number | | Percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Secondary | Geometric Mean of the Ratio in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) of Week 16 to Baseline | Changes in NT-proBNP levels in plasma are expressed by the geometric mean of the ratio of Week 16 to baseline | | Posted | | Geometric Mean | 95% Confidence Interval | Geometric mean of the ratio | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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| Other Pre-specified | Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II) | The Treatment Satisfaction Questionnaire for Medication, Version II (TSQM II) is a validated tool that evaluate the subject's satisfaction with the study treatment. It includes a total of 11 questions related to satisfaction with treatment effectiveness, side effects,convenience, and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment. | | Posted | | Median | 95% Confidence Interval | Units on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Selexipag | The subjects participated in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continued selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. |
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