OPsumit USers Registry

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Opsumit (macitentan)

• Registration Number: NCT02126943
• Lead Sponsor: Actelion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study Start: 2014-04-30
• Study First Posted: 2014-04-30
• Primary Completion: 2020-04-24
• Study Completion: 2020-04-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2686

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Opsumit (macitentan)	Opsumit (macitentan)	10 mg tablets

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.	1 year

Trial Locations

Locations (1)

Investigator Site; 🇵🇷 Ponce, Puerto Rico