Trial · NCT01389856
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Treatment Failure | From baseline to up to 21 days | Treatment failure was defined as the need for extra corporeal membrane oxygenation or initiation of alternative pulmonary vasodilator treatment |
| Primary | Time to Complete Weaning From iNO | From baseline to up to 21 days | Calculated from the time from first study drug administration to complete weaning from iNO. Weaning from iNO was considered complete if there was no requirement for the re-initiation of iNO within 24 h after stopping |
| Primary | Time to Complete Weaning From Mechanical Ventilation | From baseline to up to 21 days | Calculated from the time from first study drug administration to complete weaning from mechanical ventilation |
| Secondary | Percentage of Patients Requiring Re-initiation of iNO Therapy | From baseline to up to 21 days | Re-initiation of iNO therapy following weaning from iNO therapy |
| Secondary | Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment | From baseline to up to 14 days | The presence of PH was assessed by echocardiography. PH was reported as 'present' if at least one of the following criteria was met: * Shunt through ductus arteriosus was either 'predominant right to left' or 'bidirectional' * Shunt through foramen ovale was either 'predominant right to left' or 'bidirectional' * Marked right ventricular dilation was ticked 'present' * Paradoxical shift of intraventricular septum was ticked 'present' * Right ventricular systolic pressure (mmHg) was \> 2/3 of the reported systemic blood pressure |
| Secondary | Change in Oxygenation Index (OI) From Baseline to 3 Hours Following Study Drug Administration | 3 hours | The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood. |
| Secondary | Change in Oxygenation Index (OI) From Baseline to 5 Hours Following Study Drug Administration | 5 hours | The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood. |
| Secondary | Change in Oxygenation Index (OI) From Baseline to 12 Hours Following Study Drug Administration | 12 hours | The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood. |
| Secondary | Change in Oxygenation Index (OI) From Baseline to 24 Hours Following Study Drug Administration | 24 hours | The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood. |
| Secondary | Change in Oxygenation Index (OI) From Baseline to 48 Hours Following Study Drug Administration | 48 hours | The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood. |
| Secondary | Change in Oxygenation Index (OI) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood. |
| Secondary | Change in Arterial Blood Gas (ABG) pH From Baseline to 72 Hours Following Study Drug Administration | 72 hours | pH was determined in arterial blood samples at baseline and 72 h after the first study drug administration |
| Secondary | Change in Arterial Blood Oxygen Saturation (SaO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | SaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration |
| Secondary | Change in Partial Pressure of Oxygen (PaO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration | 72 hours | PaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration |
| Secondary | Change in Partial Pressure of Carbon Dioxide (PaCO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration | 72 hours | PaCO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration |
| Secondary | Change in Pre-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration |
| Secondary | Change in Post-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration |
| Secondary | Change in Fraction of Inspired Oxygen (FiO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | FiO2 was determined according to each study centers' standard procedure at baseline and 72 h after the first study drug administration |
| Secondary | Maximum Whole Blood Concentration (Cmax) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1 | up to 12 hours | Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Cmax was obtained directly from the measured concentrations. Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg. |
| Secondary | Cmax for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 5 | 12 hours | Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Cmax obtained directly from the measured concentrations . Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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