OPsumit USers Registry

NCT02126943 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2686

Last updated 2025-03-30

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126943 on ClinicalTrials.gov