At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 709 enrolled
Drug / intervention
ACT-293987drug
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.
Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension
In Brief
A Phase 3 clinical trial evaluating ACT-293987 for Pulmonary Arterial Hypertension. Completed, enrolled 709 participants across 157 sites in 38 countries.
Detailed Summary
Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesArgentina, Australia, Austria, Belarus, Belgium, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartJul 2010
Primary CompletionAug 2021
TodayJul 2026
First PostedApr 28, 2010
Enrollment StartJul 7, 2010
Primary CompletionAug 26, 2021
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 16.2 years ago
Interventions
ACT-293987drug
Tablets, twice daily