A1481283 follow up investigation for pts completing the A1481276 study

• Research type

  Research Study

• Full title

  A follow up investigation for patients completing study A1481276 to investigate developmental progress 12 and 24 months following completion of sildenafil treatment.

• IRAS ID

  89735

• Contact name

  Christine Pierce

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

• Eudract number

  2010-021266-30

• Research summary

  This study is designed to monitor the developmental progress of patients previously enrolled in the A1481276 study. All patients who received sildenafil treatment during study A1481276 will be eligible to participate in this follow up study. This study will assess the long term safety and neurological development of patients at 12 months and 24 months after completion of sildenafil treatment.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/1680

• Date of REC Opinion

  14 Dec 2011

• REC opinion

  Further Information Favourable Opinion