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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021266-30 | EudraCT Number |
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This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.
This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-interventional | Other | non-interventional |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Physical Examination Abnormalities at Month 12 | Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion. | Month 12 |
| Number of Participants With Physical Examination Abnormalities at Month 24 | Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion. | Month 24 |
| Number of Participants With Clinically Significant Medical History at Month 12 | Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator. | Month 12 |
| Number of Participants With Clinically Significant Medical History at Month 24 | Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator. | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at Month 12 | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported. | Month 12 |
| Overall Survival at Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
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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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All participants who received sildenafil treatment during study A1481276 (NCT01069861) were eligible for enrollment in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil | Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported. |
| Month 24 |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Month 12 |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS) included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil | Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Participants With Physical Examination Abnormalities at Month 12 | Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion. | Full Analysis Set (FAS) included all enrolled participants. | Posted | Number | participants | Month 12 |
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| Primary | Number of Participants With Physical Examination Abnormalities at Month 24 | Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion. | Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1). | Posted | Month 24 |
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| Primary | Number of Participants With Clinically Significant Medical History at Month 12 | Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator. | Full Analysis Set (FAS) included all enrolled participants. | Posted | Number | participants | Month 12 |
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| Primary | Number of Participants With Clinically Significant Medical History at Month 24 | Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator. | Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1). | Posted | Month 24 |
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| Secondary | Overall Survival at Month 12 | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported. | Full Analysis Set (FAS) included all enrolled participants. | Posted | Number | participants | Month 12 |
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| Secondary | Overall Survival at Month 24 | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported. | Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1). | Posted | Month 24 |
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| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | FAS included all enrolled participants. | Posted | Number | participants | Up to Month 12 |
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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 | Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24. | 0 | 1 | 0 | 1 |
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Results at Month 24 were not reported as the participant lost to follow-up after Month 12.
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 |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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