Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01431716 | Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension | PHASE3 | COMPLETED | 42 | — | — | Mar 1, 2011 | Jul 1, 2012 | Jan 13, 2015 | 8 | Belgium, Canada +4 |
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
| Arm | Type | Description |
|---|---|---|
| EFI/ACT-385781A | EXPERIMENTAL | EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump |
| Name | Type | Description |
|---|---|---|
| EFI/ACT-385781A | DRUG | - |
Inclusion Criteria: 1. Male or female aged 18 years and above 2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective tissue diseases or Drugs and toxins 3. Patients treated with F...