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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 April 11, 2018

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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A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment
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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil
Pulmonary Hypertension, Persistent, of the Newborn
Other: non-interventional
non-interventional
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 1 Year   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01801982
A1481283
2010-021266-30 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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