ong 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)
Phase 2
Completed
- Conditions
- 1003745410014523PAH high blood pressure in the lungs
- Registration Number
- NL-OMON41712
- Lead Sponsor
- Actelion Registration Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
Subject with CTEPH having completed the double-blind (DB) AC-055E201 / MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
Exclusion Criteria
- Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Exploratory efficacy endpoints<br /><br>- Change from baseline to each scheduled time point in exercise capacity, as<br /><br>measured by the 6-minute walk distance (6MWD)<br /><br>- Change from baseline to each scheduled time point in Borg dyspnea index<br /><br>collected at the end of the 6-minute walk test (6MWT)<br /><br>- Proportion of subjects with worsening of WHO FC from baseline to each<br /><br>scheduled time point.<br /><br><br /><br>Safety and tolerability endpoints<br /><br>- Treatment-emergent AEs up to 30 days after study drug discontinuation.<br /><br>- AEs leading to premature discontinuation of study drug.<br /><br>- Treatment-emergent SAEs up to 30 days after study drug discontinuation.<br /><br>- Treatment-emergent marked laboratory abnormalities [as detailed in Appendix<br /><br>4] upto 30 days after study drug discontinuation.<br /><br>- Change in vital signs (BP [i.e., DBP and SBP],</p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory efficacy endpoints<br /><br>- Change from baseline to each scheduled time point in exercise capacity, as<br /><br>measured by the 6-minute walk distance (6MWD)<br /><br>- Change from baseline to each scheduled time point in Borg dyspnea index<br /><br>collected at the end of the 6-minute walk test (6MWT)<br /><br>- Proportion of subjects with worsening of WHO FC from baseline to each<br /><br>scheduled time point.<br /><br><br /><br>Safety and tolerability endpoints<br /><br>- Treatment-emergent AEs up to 30 days after study drug discontinuation.<br /><br>- AEs leading to premature discontinuation of study drug.<br /><br>- Treatment-emergent SAEs up to 30 days after study drug discontinuation.<br /><br>- Treatment-emergent marked laboratory abnormalities [as detailed in Appendix<br /><br>4] upto 30 days after study drug discontinuation.<br /><br>- Change in vital signs (BP [i.e., DBP and SBP],</p><br>