At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,686 enrolled
Drug / intervention
Opsumit (macitentan)drug
Likely dose
Opsumit (macitentan) 10 mgfrom 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.
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
In Brief
An observational study evaluating Opsumit (macitentan) for Pulmonary Arterial Hypertension. Completed, enrolled 2,686 participants across 146 sites in 2 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesPuerto Rico, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartApr 2014
Primary CompletionApr 2020
TodayJul 2026
First PostedApr 30, 2014
Enrollment StartApr 30, 2014
Primary CompletionApr 24, 2020
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 12.2 years ago
Interventions
Opsumit (macitentan)drug
10 mg tablets