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

Last updated on October 12, 2019

FOR MORE INFORMATION
Study Location
Great Ormond Street Hospital, Paediatric Intensive Care
London, , WC1N 3JH United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Persistent Pulmonary Hypertension
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.

NCT01801982
Pfizer
Completed
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

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Descriptive Information
Brief TitleA Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Official TitleA Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
Brief SummaryThis 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 DescriptionThis 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 TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
ConditionPulmonary Hypertension, Persistent, of the Newborn
InterventionOther: non-interventional
non-interventional
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: February 27, 2013)
1
Original Actual EnrollmentSame as current
Actual Study Completion DateDecember 2013
Actual Primary Completion DateDecember 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
Agesup to 1 Year   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01801982
Other Study ID NumbersA1481283
2010-021266-30 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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