Trial · NCT01720524
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
NCT01720524, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2020-03-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn. Trials, record NCT01720524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01720524
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
- NCT number
- NCT01720524
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 59 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Pulmonary Hypertension, Familial Persistent, of the Newborn
- Interventions
- placebo, iv sildenafil
- First posted
- 2012-11-02
- Last updated
- 2021-08-16
- Other registries' IDs
- eudract:2012-002619-24
- Results first posted
- 2020-03-25
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | Time in days, on iNO treatment, for participants without iNO treatment failure, was calculated 14 days from the initiation of IV study drug or hospital discharge, whichever occurred first. iNO treatment failure was defined as need for additional treatment targeting PPHN, need for extra corporeal membrane oxygenation (ECMO), or death during the study. |
| Primary | Treatment Failure Rate | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | Treatment failure rate was defined as percentage of participants who needed additional treatment targeting PPHN, needed ECMO, or died during the study. |
| Secondary | Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | Time in days, from initiation of IV study drug to final weaning of mechanical ventilation among participants achieving final weaning of mechanical ventilation for PPHN was evaluated. Kaplan-Meier method was used for estimation. For participants with mechanical ventilation beyond 336 hours (14 days) from initiation of IV study drug, data was censored at 14 days. |
| Secondary | Time From Initiation of Intravenous (IV) Study Drug to First Treatment Failure | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | Time in days, from initiation of IV study drug to first treatment failure (defined as need for additional treatment targeting PPHN, need for ECMO, or death) for participants with treatment failure was evaluated. Kaplan-Meier method was used for estimation. For participants without treatment failure by the endpoint assessment date, data was censored at the endpoint assessment date. |
| Secondary | Percentage of Participants With Individual Components of Treatment Failure | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | Percentage of participants with individual components of treatment failure (need to start additional treatment targeting PPHN, need to start ECMO, or death) were evaluated. Some participants could have had multiple qualifying events for treatment failure. |
| Secondary | Change From Baseline in Oxygenation Index (OI) at Hours 6, 12 and 24 Post-Infusion | Baseline, Hours 6, 12 and 24 after start of infusion | Oxygenation index was calculated as the product of fraction of inspired oxygen (FiO2) and mean airway pressure divided by partial pressure of oxygen dissolved in arterial blood (PaO2) \[(FiO2\*mean airway pressure)/PaO2\] measured in centimeter of water per 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 dissolved in the arterial blood. |
| Secondary | Change From Baseline in Differential Saturation at Hours 6, 12 and 24 Post-Infusion | Baseline, Hours 6, 12 and 24 after start of infusion | Differential oxygenation saturation is a simple way to detect the right-to left shunting at ductus arteriosus using 2 pulse oximeters. It is the difference between pre-ductal and post-ductal sites pulse oxygen saturation (SpO2). Where, pre-duct refers to right upper extremity and post-duct refers to lower limb. 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 Fraction of Inspired Oxygen (P/F) at Hours 6, 12 and 24 | Baseline, Hours 6, 12 and 24 after start of infusion | The ratio of partial pressure of arterial oxygen to fraction of inspired oxygen is a ratio 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 | Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite | Loading dose, Day 1: prior to the start of infusion, 5, 30 minutes after end of loading infusion; Maintenance dose: 48 to 72, 96 to 120 hours during infusion and immediately prior to end of maintenance infusion (up to maximum on Day 14) | Cmax was obtained for Sildenafil and its major metabolite UK-103,320. |
| Secondary | Total Plasma Clearance (CL) of Sildenafil and Its Metabolite | Loading dose: prior to the start of infusion, 5, 30 minutes after end of loading infusion on Day 1; Maintenance dose: between 48 to 72, 96 to 120 hours during infusion and immediately prior to end of infusion on Day 1 | CL is volume of the body fluid/ plasma from which the drug or the metabolite is completely removed per unit time. CL was obtained for Sildenafil and its major metabolite UK-103,320. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | The intent-to-treat population (ITT) included all randomized participants treated with study treatment. Here Overall number of participants analyzed signifies number of participants without iNO treatment failure. | days | LEAST_SQUARES_MEAN |
| PRIMARY | Treatment Failure Rate | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | The ITT population included all randomized participants treated with study treatment. | percentage of participants | NUMBER |
| SECONDARY | Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | The ITT population included all randomized participants treated with study treatment. | days | MEDIAN |
| SECONDARY | Time From Initiation of Intravenous (IV) Study Drug to First Treatment Failure | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | The ITT population included all randomized participants treated with study treatment. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Individual Components of Treatment Failure | 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days) | The ITT population included all randomized participants treated with study treatment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Oxygenation Index (OI) at Hours 6, 12 and 24 Post-Infusion | Baseline, Hours 6, 12 and 24 after start of infusion | The ITT population included all randomized participants treated with study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | cmH2O/mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Differential Saturation at Hours 6, 12 and 24 Post-Infusion | Baseline, Hours 6, 12 and 24 after start of infusion | The ITT population included all randomized participants treated with study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | percentage of hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to Fraction of Inspired Oxygen (P/F) at Hours 6, 12 and 24 | Baseline, Hours 6, 12 and 24 after start of infusion | The ITT population included all randomized participants treated with study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite | Loading dose, Day 1: prior to the start of infusion, 5, 30 minutes after end of loading infusion; Maintenance dose: 48 to 72, 96 to 120 hours during infusion and immediately prior to end of maintenance infusion (up to maximum on Day 14) | Pharmacokinetic (PK) analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period. | nanogram per milliliter | MEAN |
| SECONDARY | Total Plasma Clearance (CL) of Sildenafil and Its Metabolite | Loading dose: prior to the start of infusion, 5, 30 minutes after end of loading infusion on Day 1; Maintenance dose: between 48 to 72, 96 to 120 hours during infusion and immediately prior to end of infusion on Day 1 | PK analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period. | Liters/hour | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group415
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure | IV Sildenafil | 4.1 | 95% Confidence Interval 2.58 to 5.58 | days | |
| Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure | Placebo | 4.1 | 95% Confidence Interval 2.70 to 5.50 | days | |
| Treatment Failure Rate | IV Sildenafil | 27.6 | 95% Confidence Interval 11.3 to 43.9 | percentage of participants | |
| Treatment Failure Rate | Placebo | 20.0 | 95% Confidence Interval 5.7 to 34.3 | percentage of participants | |
| Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation | IV Sildenafil | 8.3 | 95% Confidence Interval 5.46 to 11.75 | days | |
| Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation | Placebo | 7.3 | 95% Confidence Interval 5.46 to 10.78 | days | |
| Time From Initiation of Intravenous (IV) Study Drug to First Treatment Failure | IV Sildenafil | NA | 95% Confidence Interval NA to NA | days | |
| Time From Initiation of Intravenous (IV) Study Drug to First Treatment Failure | Placebo | NA | 95% Confidence Interval NA to NA | days | |
| Percentage of Participants With Individual Components of Treatment Failure | IV Sildenafil | Additional Treatment Targeting PPHN | 13.8 | 95% Confidence Interval 3.9 to 31.7 | percentage of participants |
| Percentage of Participants With Individual Components of Treatment Failure | Placebo | Additional Treatment Targeting PPHN | 10.0 | 95% Confidence Interval 2.1 to 26.5 | percentage of participants |
1 to 10 of 415Source ClinicalTrials.gov
See all 415 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | IV Sildenafil | 29 | |
| Part A | STARTED | Placebo | 30 | |
| Part A | COMPLETED | IV Sildenafil | 22 | |
| Part A | COMPLETED | Placebo | 18 | |
| Part A | NOT COMPLETED | IV Sildenafil | 7 | |
| Part A | NOT COMPLETED | Placebo | 12 | |
| Part B | STARTED | IV Sildenafil | 27 | |
| Part B | STARTED | Placebo | 26 | |
| Part B | COMPLETED | IV Sildenafil | 22 | |
| Part B | COMPLETED | Placebo | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events724
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 | Part A: IV Sildenafil | 4 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Placebo | 3 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: IV Sildenafil | 1 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Placebo | 2 | 26 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A: IV Sildenafil | 2 | 29 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A: Placebo | 1 | 30 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part B: IV Sildenafil | 0 | 27 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part B: Placebo | 0 | 26 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part A: IV Sildenafil | 0 | 29 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part A: Placebo | 1 | 30 |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: IV Sildenafil | 2 | 29 |
| Total, all-cause mortality | Part A: Placebo | 1 | 30 |
| Total, all-cause mortality | Part B: IV Sildenafil | 0 | 27 |
| Total, all-cause mortality | Part B: Placebo | 2 | 26 |
| Total, other adverse events | Part A: IV Sildenafil | 20 | 29 |
| Total, other adverse events | Part A: Placebo | 19 | 30 |
| Total, other adverse events | Part B: IV Sildenafil | 14 | 27 |
| Total, other adverse events | Part B: Placebo | 15 | 26 |
| Total, serious adverse events | Part A: IV Sildenafil | 7 | 29 |
| Total, serious adverse events | Part A: Placebo | 2 | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34052232 | 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 |
|---|
| IV Sildenafil vs Placebo: Number of Participants With Laboratory Abnormalities |
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/NCT01720524
GET https://conductscience.org/api/trials/v1/NCT01720524/registered?page=2