MERIT-1
Research type
Research Study
Full title
Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension
IRAS ID
137397
Contact name
Luke Howard
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2013-002950-56
Clinicaltrials.gov Identifier
Research summary
This study is a phase II, prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study in subjects with inoperable chronic thromboembolic pulmonary hypertension.
Study participants, male or female, aged 18 to 80, will receive either placebo or 10mg of Macitentan, once daily. The study is designed to assess the safety, effectiveness and tolerability of Macitentan and to evaluate the effects of macitentan on Pulmonary Vascular Resistance. Approximately 78 patients will be enrolled in 2 groups (39 subjects per group).
The screening period will last up to 30 days and this will be followed by the treatment period which lasts for 24 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 8 months for each subject enrolled. (An open-label study extension is also planned and will be provided as a separate protocol).
The study is also designed to investigate the effects of Macitentan vs placebo upon exercise capacity; measured by the six-minute walk test, dyspnoea; assessed by the Borg dyspnoea index and WHO functional class.
The exploratory objectives will evaluate the effects of macitentan versus placebo upon cardiac haemodynamic measurements, biomarkers, time to Pulmonary Hypertension (PH)-related disease progression, PH symptoms and their impact on the patient’s life. Pharmacokinetic studies will also assess the exposure of study participants to macitentan and its metabolite. Quality of life questionnaires will also be completed for all study participants.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0362
Date of REC Opinion
1 Apr 2014
REC opinion
Further Information Favourable Opinion