Trial · NCT01069861
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
NCT01069861, Phase 2, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN). Trials, record NCT01069861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01069861
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
- NCT number
- NCT01069861
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- PPHN, Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
- Interventions
- sildanefil
- First posted
- 2010-02-17
- Last updated
- 2021-02-01
- Results first posted
- 2012-12-03
- Limitations and caveats
- The study was prematurely discontinued, therefore not all data was analyzed.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO) | From start of infusion (baseline) up to Day 14 | Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment. |
| Primary | Number of Participants With Adverse Events (AEs) Based on Severity | Baseline up to 28 days after last dose | AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE:AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent/significant disability/incapacity; congenital anomaly. Severity criteria: "mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function and severe=interferes significantly with participant's usual function". |
| Primary | Number of Participants With Abnormal Laboratory Data | Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14) | Criteria for potentially clinically significant (PCS) laboratory values: hematocrit 29.2 percent (%); white blood cell (WBC) count 5.0\*10\^3, lymphocyte absolute 0.88\*10\^3, total neutrophils absolute 12.07\*10\^3, eosinophils absolute 0.50\*10\^3 per cubic millimeter (/mm\^3); calcium 6.8 milligram/deciliter (mg/dL); venous bicarbonate 47.0 milliequivalent/liter (meq/L). |
| Secondary | Change From Baseline in Oxygenation Index at Hour 6 and 12 | Baseline, Hour 6, 12 | Oxygenation Index (OI) was calculated as the product of fraction of inspired oxygen (FiO2) and Mean Airway Pressure divided by partial pressure of oxygen in arterial blood \[(FiO2\*Mean Airway Pressure)/PaO2\] measured in centimeter of water/millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level in the arterial blood. |
| Secondary | Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12 | Baseline, Hour 6, 12 | Differential oxygenation saturation between preductal and postductal sites as measured by pulse oximetry. A difference of greater than (\>) 5 percent (%) to 10% in saturation indicates right-to-left shunt through the ductus arteriosus. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood. |
| Secondary | Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12 | Baseline, Hour 6, 12 | The ratio of partial pressure of arterial oxygen and fraction of inspired oxygen is a comparison between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood. |
| Secondary | Duration of Mechanical Ventilation | Baseline up to 28 days after last dose | The number of days from the start to the stop of mechanical ventilation, if multiple ventilations occurred during the follow-up, the sum of the duration of each ventilation was used for analyses. Mechanical ventilation was defined as use of mechanical assistance or replacement of spontaneous breathing. |
| Secondary | Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO]) | Baseline up to 28 days after last dose | Time from start of treatment up to introduction of standard therapy. If participants did not receive standard therapy within 14 days after initiation of the study treatment, then Day 14 was the censoring time. |
| Secondary | Population Pharmacokinetics of Sildenafil | Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320) | Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO) | From start of infusion (baseline) up to Day 14 | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| PRIMARY | Number of Participants With Adverse Events (AEs) Based on Severity | Baseline up to 28 days after last dose | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| PRIMARY | Number of Participants With Abnormal Laboratory Data | Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14) | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| SECONDARY | Change From Baseline in Oxygenation Index at Hour 6 and 12 | Baseline, Hour 6, 12 | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| SECONDARY | Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12 | Baseline, Hour 6, 12 | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| SECONDARY | Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12 | Baseline, Hour 6, 12 | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| SECONDARY | Duration of Mechanical Ventilation | Baseline up to 28 days after last dose | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| SECONDARY | Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO]) | Baseline up to 28 days after last dose | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. | ||
| SECONDARY | Population Pharmacokinetics of Sildenafil | Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion | |||
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320) | Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil | 4 | |
| Overall Study | COMPLETED | Sildenafil | 1 | |
| Overall Study | NOT COMPLETED | Sildenafil | 3 |
Source ClinicalTrials.gov
Adverse events16
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 | Cardiac disorder | Cardiac disorders | Sildenafil | 2 | 4 | |
| other | Pericardial effusion | Cardiac disorders | Sildenafil | 1 | 4 | |
| other | Infusion site erythema | General disorders | Sildenafil | 1 | 4 | |
| other | Incorrect drug administration duration | Injury, poisoning and procedural complications | Sildenafil | 1 | 4 | |
| other | Blood lactic acid increased | Investigations | Sildenafil | 1 | 4 | |
| other | C-reactive protein increased | Investigations | Sildenafil | 1 | 4 | |
| other | Intraventricular haemorrhage | Nervous system disorders | Sildenafil | 1 | 4 | |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Sildenafil | 2 | 4 | |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Sildenafil | 1 | 4 | |
| other | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Sildenafil | 1 | 4 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil | ||
| Total, other adverse events | Sildenafil | 3 | 4 |
| Total, serious adverse events | Sildenafil | 1 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01069861
GET https://conductscience.org/api/trials/v1/NCT01069861/registered