A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

NCT01801982

Last updated date
Study Location
Great Ormond Street Hospital, Paediatric Intensive Care
London, , WC1N 3JH, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension, Persistent, of the Newborn
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-1
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Any subject who received sildenafil treatment in study A1481276.

- Signed and dated informed consent document by legal guardian.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any subject who did not receive sildenafil treatment during study A1481276.

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Pulmonary Hypertension, Persistent, of the NewbornA Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
NCT01801982
  1. London,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Official Title A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
Condition Pulmonary Hypertension, Persistent, of the Newborn
Intervention Other: non-interventional
non-interventional
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 27, 2013)
1
Original Actual Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Any subject who received sildenafil treatment in study A1481276.
  • Signed and dated informed consent document by legal guardian.

Exclusion Criteria:

  • Any subject who did not receive sildenafil treatment during study A1481276.
Sex/Gender
Sexes Eligible for Study:All
Ages up to 1 Year   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01801982
Other Study ID Numbers A1481283
2010-021266-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2014