OPsumit USers Registry
NCT02126943 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2686
Last updated 2025-03-30
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.
Conditions
Interventions
- DRUG
-
Opsumit (macitentan)
10 mg tablets
Sponsors & Collaborators
-
Actelion
lead INDUSTRY
Principal Investigators
-
V McLaughlin, MD · Chair of the OPUS scientific committee (OSC)
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2020-04-24
- Completion
- 2020-04-24
Countries
- United States
- Puerto Rico
Study Locations
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