Summary

at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Pulmonary Arterial Hypertension Hypertension Familial Primary Pulmonary Hypertension Macitentan Notapplicable

Eligibility

You can join if…

  • Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive)
  • Patients whose medical charts are available for data collection

You CAN'T join if...

  • Patient participation in the OPUS registry
  • Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product

Locations

  • University of California San Diego
    La Jolla California 93093 United States
  • Paloma Medical Group
    San Juan Capistrano California 92675 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT03197688
Study Type
Observational
Last Updated
March 21, 2018