Phase 3
Completed N=41
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT01470144 ↗Enrolled (actual)
41
Serious AEs
85.4%
Results posted
Dec 2016
Primary outcomePrimary: Treatment-emergent Adverse Events — 41 Number of patients
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Adverse Events |
41 | — |
| SECONDARY Exposure Duration |
2.44 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to initiation of any study-mandated procedure
- Patients who completed participation in study AC-066A301
- Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301
Exclusion Criteria
- Patients who prematurely discontinued study drug in study AC-066A301
- Patients for whom continued treatment with EFI is no longer considered appropriate
Data sourced from ClinicalTrials.gov (NCT01470144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.