MAESTRO: Macitentan in Eisenmenger Syndrome AC-055-305
Research type
Research Study
Full title
A Multi-Centre, double blind, randomised, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome.
IRAS ID
114841
Contact name
Michael Gatzoulis
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2012-003335-33
Clinicaltrials.gov Identifier
Research summary
This study is a prospective, multi-centre, double-blind, randomised, placebo controlled, parallel group, phase III study in subjects with Eisenmenger Syndrome. Study participants male or female, aged 18-70, will receive either placebo or 10mg of Macitentan, once daily. The study is designed to assess the safety and effectiveness of Macitentan and to evaluate the effects of macitentan on exercise capacity. At least 220 patients will be enrolled in 2 groups (110 subjects per group). A sub-study will be conducted at specialist sites where approximately 80 of the subjects (approximately 40 subjects per treatment group) will participate in additional haemodynamic measurements. The screening period will last up to 30 days and this will be followed by the treatment period which lasts for 16 weeks. All subjects will be followed up until the end of study visit (30 days after end of treatment visit). Therefore the study duration will be up to 6 months for each subject enrolled. (An open-label study extension is also planned and will be provided as a separate protocol).The study is designed to investigate the effects of Macitentan on the exercise capacity of subjects with Eisenmenger Syndrome measured by the six-minute walk test. The effect of macitentan vs. placebo will also be investigated for Quality of life, dyspnoea and WHO functional class. The haemodynamic sub-study will evaluate the efficacy of macitentan upon haemodynamic measurements.
REC name
London - Fulham Research Ethics Committee
REC reference
13/LO/0161
Date of REC Opinion
27 Feb 2013
REC opinion
Further Information Favourable Opinion