MAESTRO-OL: Macitentan in Eisenmenger Syndrome OPEN LABEL AC-055-308
Research type
Research Study
Full title
Long-term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome.
IRAS ID
114842
Contact name
Laurie Rague
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2012-004411-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 3 months, 1 days
Research summary
This study is an open-label (OL), non-comparative, multicentre, phase III, extension study of protocol AC-055-305, which aims to assess the long term safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome.
Study participants (male or female) will have completed participation in the double-blind study MAESTRO/AC-055-305 as scheduled. In this oben-label study, all study participants will receive 10mg of Macitentan, orally, once daily.
The number of study participants will be determined by the number of patients who consent to enter this open-label extension study after completing the double-blind study. Subjects will be rolled over from the AC-055-305 study to this OL study without knowledge of their previous study drug treatment (macitentan or placebo).Enrollment into this AC-055-308 OL study (OL visit 1) will be combined with the Week 16 visit (i.e. visit 6 [week 16/End of treatment] or visit 6a [week 16/ premature end of treatment], if applicable) of the double-blind AC-055-305/MAESTRO study.
After the enrollment visit, participants will visit the hospital/clinic at month 1 (Visit 2), Month 6 (Visit 3) and Months 12, 18, 24, 30, 36, 42 and 48 (Visits 4, 5, 6, 7, 8, 9 and End of treatment, respectively). In addition, participants will undergo monthly lab and safety monitoring site visits.
A post-treatment safety follow up period (30 days) will follow permanent study drug discontinuation. At the end of this safety follow up period, the end of study visit will be performed.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0603
Date of REC Opinion
25 Nov 2015
REC opinion
Further Information Favourable Opinion