OPsumit USers Registry

STUDY IDENTIFIER:

OPsumit USers Registry (OPUS)

CONDITION:

Pulmonary Hypertension

CONTACT INFO:

Terri Arndt, R.N.   |   theresa.arndt@allina.com   |   612.863.7821

DESCRIPTION:

Evaluating the safety profile of Opsumit in the post-marketing setting will provide further characterization of its use from clinical practice. This study is a 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.

CRITERIA LIST/ QUALIFICATIONS:

INCLUSION CRITERIA:

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

 

EXCLUSION CRITERIA:

  • Previous user of Opsumit defined as Patient with Opsumit therapy initiated > 30 days prior to enrollment
  • Patients enrolled in any ongoing clinical trials.

INVESTIGATORS:

Barry Cabuay, M.D.

SPONSORS:

Actelion

STATUS:

Open/Enrolling