Trial · NCT01389856
Persistent Pulmonary Hypertension of the Newborn
NCT01389856, Phase 3, Terminated, Actelion; results first posted 2015-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Persistent Pulmonary Hypertension of the Newborn. Trials, record NCT01389856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01389856
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Persistent Pulmonary Hypertension of the Newborn
- NCT number
- NCT01389856
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Persistent Pulmonary Hypertension of the Newborn
- Interventions
- Bosentan, Matching placebo
- First posted
- 2011-07-08
- Last updated
- 2025-02-04
- Results first posted
- 2015-03-23
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Treatment Failure | Bosentan | 7.7 | percentage of participants | ||
| Percentage of Patients With Treatment Failure | Placebo | 0 | percentage of participants | ||
| Time to Complete Weaning From iNO | Bosentan | 3.7 | 95% Confidence Interval 1.17 to 6.95 | days | |
| Time to Complete Weaning From iNO | Placebo | 2.9 | 95% Confidence Interval 1.26 to 4.23 | days | |
| Time to Complete Weaning From Mechanical Ventilation | Bosentan | 10.8 | 95% Confidence Interval 3.21 to 12.21 | days | |
| Time to Complete Weaning From Mechanical Ventilation | Placebo | 8.6 | 95% Confidence Interval 3.71 to 9.66 | days | |
| Percentage of Patients Requiring Re-initiation of iNO Therapy | Bosentan | 0 | percentage of participants | ||
| Percentage of Patients Requiring Re-initiation of iNO Therapy | Placebo | 0 | percentage of participants | ||
| Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment | Bosentan | 41.7 | percentage of participants | ||
| Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment | Placebo | 37.5 | percentage of participants |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosentan | 13 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Bosentan | 13 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Bosentan | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Bosentan | 3 | 13 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo | 1 | 8 | |
| other | GENERALISED OEDEMA | General disorders | Bosentan | 3 | 13 | |
| other | GENERALISED OEDEMA | General disorders | Placebo | 0 | 8 | |
| other | COAGULOPATHY | Blood and lymphatic system disorders | Bosentan | 1 | 13 | |
| other | COAGULOPATHY | Blood and lymphatic system disorders | Placebo | 1 | 8 | |
| other | VOMITING | Gastrointestinal disorders | Bosentan | 2 | 13 | |
| other | VOMITING | Gastrointestinal disorders | Placebo | 0 | 8 | |
| other | BILIRUBIN CONJUGATED INCREASED | Investigations | Bosentan | 1 | 13 | |
| other | BILIRUBIN CONJUGATED INCREASED | Investigations | Placebo | 0 | 8 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosentan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bosentan | 9 | 13 |
| Total, other adverse events | Placebo | 2 | 8 |
| Total, serious adverse events | Bosentan | 2 | 13 |
| Total, serious adverse events | Placebo | 3 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27502103 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bosentan vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01389856
GET https://conductscience.org/api/trials/v1/NCT01389856/registered?page=2