OPsumit USers Registry (OPUS)

Actelion Pharmaceuticals

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Opsumit (macitentan)

Study type: Observational

Funder types: Industry

Identifiers

NCT02126943

AC-055-503

Details and patient eligibility

About

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.

Enrollment: 2,686 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Signed ICF

Exclusion criteria

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

Patients enrolled in any ongoing clinical trials

Trial design

2,686 participants in 1 patient group

Opsumit (macitentan)

Description:

10 mg tablets

Treatment:

Drug: Opsumit (macitentan)