CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,200 enrolled
Drug / intervention
Notapplicableother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03197688
NCT03197688N/ACompleted
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Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

Actelion·observational·Posted Jun 23, 2017·Updated Mar 30, 2025

In Brief

An observational study evaluating Notapplicable for Pulmonary Arterial Hypertension. Completed, enrolled 2,200 participants across 106 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesPuerto Rico, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 23, 2017
Enrollment StartAug 3, 2017
Primary CompletionSep 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.0 years ago

Interventions

Notapplicableother

Not applicable as non-interventional study