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

Actelion Pharmaceuticals

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Other: Notapplicable

Study type: Observational

Funder types: Industry

Identifiers

NCT03197688

AC-055-510

Details and patient eligibility

About

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.

Enrollment: 2,200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

2,200 participants in 1 patient group

Notapplicable

Description:

Not applicable as non-interventional study

Treatment:

Other: Notapplicable