| Primary | Number of Subjects Experiencing Clinical Worsening | Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy). | Intent-to-Treat Population | Posted | | Count of Participants | | Participants | | From Baseline to Day 14 | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Change in Oxygenation Index (OI) | OI is an assessment of how much oxygen from the lungs enters the blood when a subject inhales, calculated as: mean airway pressure (MAP) multiplied by fraction of inspired oxygen (FiO2) divided by partial pressure of oxygen in the arterial blood (PaO2), then multiplying by 100. An OI of 15 or less indicates mild hypoxia, 16 to 25 indicates moderate hypoxia, 26 to 40 indicates severe hypoxia, and more than 40 indicates very severe hypoxia. | Intent-to-Treat Population | Posted | | Median | Full Range | units on a scale | | From Baseline to Hours 12, 24, and 72; Days 7 and 14; and/or prior to study drug discontinuation/weaning | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Change in P/F Ratio | PaO2/FiO2 ratio, also referred to as P/F Ratio, is a calculation used to assess the severity of hypoxemia, which is a condition characterized by low levels of oxygen in the blood. A low P/F ratio suggests that the patient's oxygen levels are compromised relative to the amount of oxygen being provided. | Intent-to-Treat Population | Posted | | Median | Full Range | ratio | | From Baseline to Hours 12, 24, and 72 | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Change in Pre- and Post-ductal Oxygen Saturation (SpO2) | SpO2 is an assessment of how much oxygen is in the blood, measured by a pulse oximeter. Pre-ductal SpO2 is measured in the right hand or foot and is a reflection of the amount of oxygen flowing to the brain. Post-ductal SpO2 is measured in the left hand or foot, after the blood has mixed with less oxygenated blood from the rest of the body. | Intent-to-Treat Population | Posted | | Median | Full Range | percentage of oxygen | | From Baseline to Hours 6, 12, 24, and 72 | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) | NT-proBNP is a hormone produced by the heart. Increased NT-proBNP concentration is associated with changes in right heart morphology and function. The main purpose of NT-proBNP testing is to see if the blood levels of this protein are within the expected range for a healthy individual. | Intent-to-Treat Population | Posted | | Median | Full Range | pg/mL | | From Baseline to Days 1, 2, 3, 7, and 14 (or prior to hospital discharge) | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Time to Clinical Worsening | Clinical worsening was assessed continuously during the study. Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy). | Intent-to-Treat Population | Posted | | Median | Full Range | days | | From Baseline to Day 56 | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Time to Initiation of ECMO | Start of ECMO was assessed continuously during the study. ECMO is a life-support therapy that oxygenates blood by passing it through an artificial lung. The start time of ECMO, if needed, was recorded for each subject. | Intent-to-Treat Population | Posted | | Median | Full Range | days | | From Baseline to Day 56 | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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| Secondary | Time to Discontinuation of Inhaled Nitric Oxide (iNO) | Discontinuation of iNO was assessed continuously during the study. iNO works by relaxing the blood vessels in the lungs, which makes it easier for oxygen to be delivered to the body. The stop time of iNO was recorded for each subject. | Intent-to-Treat Population | Posted | | Median | Full Range | days | | From Baseline to Day 56 | | | | ID | Title | Description |
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| OG000 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | | OG001 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose. Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). |
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