OPsumit USers Registry

• Status: Completed
• Trial end date: 2020-04-24
• Target enrollment: 0
• Participant gender: All

Summary

Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Macitentan

Criteria

Inclusion Criteria:

Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.

Signed ICF

Exclusion Criteria:

Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.

Patients enrolled in any ongoing clinical trials