At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
rodatristat ethyl 300 mg tablet BID +2 moredrug
Likely dose
rodatristat ethyl 300 mg tablet BIDfrom 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.
A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension
In Brief
A Phase 2 clinical trial evaluating rodatristat ethyl 300 mg tablet BID, rodatristat ethyl 600 mg BID, and 1 other intervention for Pulmonary Arterial Hypertension. Completed, enrolled 108 participants across 64 sites in 17 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, France, Germany, Italy, Latvia, Moldova, Poland, Serbia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartMar 2021
Primary CompletionJun 2023
Study CompletionAug 2023
TodayJul 2026
First PostedJan 15, 2021
Enrollment StartMar 15, 2021
Primary CompletionJun 5, 2023
Study CompletionAug 28, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.5 years ago
Interventions
rodatristat ethyl 300 mg tablet BIDdrug
rodatristat ethyl 300 mg tablet + matching placebo tablet twice daily on top of standard of care
rodatristat ethyl 600 mg BIDdrug
2 rodatristat ethyl 300 mg tablets twice daily on top of standard of care
Placebodrug
2 matching placebo tablets on top of standard of care