Summary

at UCLA
study started
estimated completion:

Description

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.

Official Title

US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice

Keywords

Pulmonary Arterial Hypertension PAH Hypertension Familial Primary Pulmonary Hypertension Macitentan Opsumit (macitentan)

Eligibility

You can join if…

Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.

Signed ICF

You CAN'T join if...

Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.

Patients enrolled in any ongoing clinical trials

Locations

  • Investigator Site accepting new patients
    Los Angeles California 90095-1690 United States
  • Investigator Site accepting new patients
    La Jolla California 92093 United States
  • Investigator Site accepting new patients
    Los Angeles California 90211 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT02126943
Study Type
Observational
Last Updated