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Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

NCT03197688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2025-03-30

No results posted yet for this study

Summary

The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Conditions

Interventions

OTHER

Notapplicable

Not applicable as non-interventional study

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-03
Primary Completion
2018-09-06
Completion
2018-09-06
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT03197688 on ClinicalTrials.gov