OPsumit USers Registry

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigator Site, Ponce, PR, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opsumit (macitentan)

Drug

10 mg tablets

Other names: ACT-064992

Primary outcomes

To estimate incidence rates for specified outcomes.

Time frame: 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 outcomes

To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.

Time frame: 1 year

Other outcomes

To describe PAH treatment patterns at enrollment and during observation period.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice

Acronym: OPUS

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Apr 30, 2014
Registry last updated: Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed