MERIT-2
Research type
Research Study
Full title
Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
IRAS ID
155826
Contact name
Luke Howard
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2013-003457-25
Clinicaltrials.gov Identifier
Research summary
Summary of Research
This is a phase II, single-arm, open-label (OL), 24 month extension study in subjects with inoperable chronic thromboembolic pulmonary hypertension. Subjects who complete the 24 weeks of the Double-Blind (DB) MERIT-1 study as scheduled can be enrolled into this MERIT-2 OL extension study. Subjects will be rolled over from the MERIT-1 study to this OL study without knowledge of their previous study treatment (macitentan 10 mg or placebo).
All study participants in this open-label extension study will receive 10 mg of Macitentan, once daily for a treatment period of up to 24 months. All subjects will be requested to complete a safety follow up visit (30 days after the end of treatment).
The study is designed to investigate the safety, tolerability and efficacy effects of macitentan in subjects with inoperable CTEPH beyond the 24 weeks of treatment in the DB MERIT-1 study.
The exploratory objectives will evaluate the long-term effects of macitentan on exercise capacity; measured by the 6-minute walk distance test (6MWD), dyspnoea; assessed by the Borg dyspnoea index and WHO functional class. Long-term safety and tolerability endpoints will include assessment of adverse events, laboratory results and vital signs during the study and up to 30 days after drug discontinuation.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1370
Date of REC Opinion
22 Sep 2014
REC opinion
Further Information Favourable Opinion