Pulmonary Arterial Hypertension
Conditions
Keywords
PAH, pulmonary arterial hypertension
Brief 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.
Interventions
DRUGOpsumit (macitentan)
10 mg tablets
Sponsors
Actelion
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To estimate incidence rates for specified outcomes. | 1 year | Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death. |
Secondary
| Measure | Time frame |
|---|---|
| To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period. | 1 year |
Other
| Measure | Time frame |
|---|---|
| To describe PAH treatment patterns at enrollment and during observation period. | 1 year |
Countries
Puerto Rico, United States
Outcome results
None listed