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Clinical Trial Summary

The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) who were previously treated with macitentan in clinical studies.


Clinical Trial Description

The purpose of this study is to provide continued treatment with macitentan to subjects with PAH who participated or participate in "parent studies" in France and to continue to accrue long-term safety data. "Parent study/studies" refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH (NCT00667823, NCT02112487, NCT02310672, NCT02968901, NCT02558231) and may be completed before the participating subjects have access to commercial macitentan in their country of residence. The "parent studies" are fully or partially running in France where no access to commercial macitentan is expected in the near future. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03422328
Study type Interventional
Source Actelion
Contact
Status Enrolling by invitation
Phase Phase 3
Start date April 4, 2018
Completion date May 2, 2021

See also
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