At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
APD811 +1 moredrug
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.
A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension
In Brief
A Phase 2 clinical trial evaluating APD811 and Placebo for Pulmonary Arterial Hypertension. Completed, enrolled 61 participants across 35 sites in 9 countries.
Detailed Summary
The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, Bulgaria, Czechia, Hungary, Poland, Romania, Serbia, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartDec 2014
Primary CompletionJun 2017
TodayJul 2026
First PostedOct 30, 2014
Enrollment StartDec 1, 2014
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.7 years ago
Interventions
APD811drug
Placebodrug
Placebo