At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 550 enrolled
Drug / intervention
Macitentandrug
Likely dose
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.
Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
In Brief
A Phase 3 clinical trial evaluating Macitentan for Pulmonary Arterial Hypertension. Completed, enrolled 550 participants across 158 sites in 36 countries.
Detailed Summary
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartOct 2008
Primary CompletionDec 2020
TodayJul 2026
First PostedApr 28, 2008
Enrollment StartOct 17, 2008
Primary CompletionDec 7, 2020
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 18.2 years ago
Interventions
Macitentandrug
Tablet, oral administration, 10 mg dose once daily