SERAPHIN Open Label

• Research type

  Research Study

• Full title

  Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension

• IRAS ID

  87443

• Contact name

  John Gerard Coghlan

• Sponsor organisation

  Actelion Pharmaceuticals Ltd

• Eudract number

  2007-003694-27

• Clinicaltrials.gov Identifier

  NCT00667823

• Research summary

  This study is a long-term, open-label study in patients with pulmonary arterial hypertension who have already completed the Seraphin double-blind study. This study is to assess the long-term safety and tolerability of the study drug ACT-064992. Patients will initially remain in the study for one year until data has been reviewed by the MHRA and an extension granted.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1825

• Date of REC Opinion

  17 Nov 2011

• REC opinion

  Favourable Opinion