RETRO: Retrospective, chart review of PAH dosing medication. Version 1
Research type
Research Study
Full title
RETRO: A Retrospective, multicEnter chart Review to collect dOsing information of PAH background medication in subjects who participated in the AC-055-302 (SERAPHIN) double-blind randomized study.
IRAS ID
248951
Contact name
John Gerrard (Gerry) Coghlan
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
In the AC-055-302 SERAPHIN study, Pulmonary Arterial Hypertension (PAH)background medication was allowed if present at stable dose for at least 3 months at the time of randomisation. A total of 471 subjects randomised in the AC-055-302 study received PAH background medication at the time of randomisation. The type and route of medication as well as the treatment start and end dates were captured in the case report form (CRF). However, the dosing information of PAH background medication was not captured. The purpose of this study is to retrospectively collect dosing information of PAH background medication administered during the AC-055-302 study to further characterise their use. Analysis of efficacy, by dose category will be compared to efficacy in subjects who did not receive PAH background medication at the time of randomisation. Efficacy data will be taken from the AC-055-302 study database.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0539
Date of REC Opinion
12 Jul 2018
REC opinion
Favourable Opinion