A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: January 8, 2013
Last updated: November 26, 2013
Last verified: November 2013
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.
Pulmonary Hypertension, Persistent, of the Newborn
||Time Perspective: Prospective
||A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
Primary Outcome Measures:
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
- Overall Survival (OS) [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||10 Months to 14 Months
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
- Any subject who received sildenafil treatment in study A1481276.
- Signed and dated informed consent document by legal guardian.
- Any subject who did not receive sildenafil treatment during study A1481276.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801982
|Great Ormond Street Hospital, Paediatric Intensive Care
|London, United Kingdom, WC1N 3JH |
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 8, 2013
||November 26, 2013
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Pfizer:
PPHN; development progress after PPHN; developmental progress after sildenafil.
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Persistent Fetal Circulation Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Phosphodiesterase 5 Inhibitors
Molecular Mechanisms of Pharmacological Action