OPUS Registry

Condition

  • Pulmonary hypertension


Study Name

U.S.-Based, Observational Drug Registry of Opsumit (Macitentan) New Users in Clinical Practice (IRB no. 36293)


Summary

This observational study focuses on patients who are initiating therapy with a drug called Opsumit for the treatment of pulmonary arterial hypertension or another etiology (cause of disease). The purpose of the OPUS registry is to better understand the use of Opsumit in the clinical practice, including further characterization of the safety profile for the drug. Other goals include describing the demographic and clinical characteristics of patients treated with Opsumit. Opsumit is approved by the U.S. Food and Drug Administration for the treatment of pulmonary arterial hypertension.


Eligibility

Key Inclusion Criteria:

  • Patients newly treated with Opsumit defined as a new user of therapy, initiated less than or equal to 30 days prior to enrollment visit or at enrollment
  • Signed informed consent

Key Exclusion Criteria:

  • Previous user of Opsumit defined as patient who initiated therapy more than 30 days prior to enrollment
  • Patients enrolled in any ongoing clinical trials

Please see additional list of inclusion and exclusion criteria.


Principal Investigator

Antoine Hage, MD


Contact

Lucilla Garcia
Phone: 310-248-7134
Email: lucilla.garcia@cshs.org