Trial · NCT01389856
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Treatment Failure | From baseline to up to 21 days | Randomized and treated patients | percentage of participants | NUMBER |
| PRIMARY | Time to Complete Weaning From iNO | From baseline to up to 21 days | Randomized and treated patients | days | MEDIAN |
| PRIMARY | Time to Complete Weaning From Mechanical Ventilation | From baseline to up to 21 days | Randomized and treated patients | days | MEDIAN |
| SECONDARY | Percentage of Patients Requiring Re-initiation of iNO Therapy | From baseline to up to 21 days | Randomized and treated patients | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment | From baseline to up to 14 days | Randomized and treated patients | percentage of participants | NUMBER |
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to 3 Hours Following Study Drug Administration | 3 hours | Randomized and treated patients | oxygenation index | MEDIAN |
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to 5 Hours Following Study Drug Administration | 5 hours | Randomized and treated patients | oxygenation index | MEDIAN |
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to 12 Hours Following Study Drug Administration | 12 hours | Randomized and treated patients | oxygenation index | MEDIAN |
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to 24 Hours Following Study Drug Administration | 24 hours | Randomized and treated patients | oxygenation index | MEDIAN |
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to 48 Hours Following Study Drug Administration | 48 hours | Randomized and treated patients with available data | oxygenation index | MEDIAN |
| SECONDARY | Change in Oxygenation Index (OI) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | oxygenation index | MEDIAN |
| SECONDARY | Change in Arterial Blood Gas (ABG) pH From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | pH | MEDIAN |
| SECONDARY | Change in Arterial Blood Oxygen Saturation (SaO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | percentage saturation | MEDIAN |
| SECONDARY | Change in Partial Pressure of Oxygen (PaO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | mm Hg | MEDIAN |
| SECONDARY | Change in Partial Pressure of Carbon Dioxide (PaCO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | mm Hg | MEDIAN |
| SECONDARY | Change in Pre-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | percentage saturation | MEDIAN |
| SECONDARY | Change in Post-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | percentage saturation | MEDIAN |
| SECONDARY | Change in Fraction of Inspired Oxygen (FiO2) From Baseline to 72 Hours Following Study Drug Administration | 72 hours | Randomized and treated patients with available data | percentage of oxygen | MEDIAN |
| 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 | Pharmacokinetic (PK) analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 5 | 12 hours | PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints. | ng/mL | GEOMETRIC_MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01389856/outcomes