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See termination reason in detailed description.
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Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
Letter to investigator dated 18 June 2012 that study was to be terminated. Study terminated due to evolved and widespread use of standard of care, relevance of study questioned. No safety reasons or issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildanefil | Drug | Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO) | Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment. | From start of infusion (baseline) up to Day 14 |
| Number of Participants With Adverse Events (AEs) Based on Severity | 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". | Baseline up to 28 days after last dose |
| Number of Participants With Abnormal Laboratory Data | 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). | Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Oxygenation Index at Hour 6 and 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Study Medication | The duration of the infusion was determined as per investigator's discretion up to Day 7 or Day 14. | Baseline up to Day 14 |
Inclusion Criteria:
72 hours of age; and > or = to 34 weeks gestational age.
Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure associated with:
Oxygenation Index (OI) >15 and <60 calculated
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital, Paediatric Intensive Care | London | WC1N 3JH | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil | Sildenafil citrate administered intravenously at a loading dose of 0.1 milligram per kilogram (mg/kg) over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg per hour (mg/kg/hr) intravenous infusion up to 14 days, based on the need of individual participant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline, Hour 6, 12 |
| Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 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. | Baseline, Hour 6, 12 |
| 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 | 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. | Baseline, Hour 6, 12 |
| Duration of Mechanical Ventilation | 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. | Baseline up to 28 days after last dose |
| Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO]) | 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. | Baseline up to 28 days after last dose |
| Population Pharmacokinetics of Sildenafil | 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. | 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 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil | Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO) | Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment. | 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. | Posted | From start of infusion (baseline) up to Day 14 |
|
| |||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) Based on Severity | 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". | 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. | Posted | Baseline up to 28 days after last dose |
|
| |||||||||||||||||||
| Primary | Number of Participants With Abnormal Laboratory Data | 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). | 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. | Posted | Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14) |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Oxygenation Index at Hour 6 and 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. | 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. | Posted | Baseline, Hour 6, 12 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 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. | 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. | Posted | Baseline, Hour 6, 12 |
|
| |||||||||||||||||||
| 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 | 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. | 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. | Posted | Baseline, Hour 6, 12 |
|
| |||||||||||||||||||
| Secondary | Duration of Mechanical Ventilation | 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. | 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. | Posted | Baseline up to 28 days after last dose |
|
| |||||||||||||||||||
| Secondary | Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO]) | 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. | 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. | Posted | Baseline up to 28 days after last dose |
|
| |||||||||||||||||||
| Secondary | Population Pharmacokinetics of Sildenafil | 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. | Not Posted | 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 | Participants | |||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320) | 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. | Posted | 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 |
|
| ||||||||||||||||||||
| Other Pre-specified | Duration of Study Medication | The duration of the infusion was determined as per investigator's discretion up to Day 7 or 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. | Posted | Baseline up to Day 14 |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil | Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant. | 1 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital pneumonia | Congenital, familial and genetic disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Persistent foetal circulation | Congenital, familial and genetic disorders | MedDRA v15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Incorrect drug administration duration | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
|
The study was prematurely discontinued, therefore not all data was analyzed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010547 | Persistent Fetal Circulation Syndrome |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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