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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02279160 | Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension | PHASE2 | COMPLETED | 61 | — | — | Dec 1, 2014 | Jun 1, 2017 | Jul 14, 2020 | 35 | United States, Australia +7 |
Measurements of PVR from right heart catheterization were obtained prior to Day 1 of the dose titration period and at the end of the maintenance period (Week 22), approximately 4 hours after the last dose of study drug.
The 6MWT was conducted according to the modified guidelines issued by the American Thoracic Society prior to Day 1 of the dose titration period and at the end of the maintenance period (Week 22).
| Arm | Type | Description |
|---|---|---|
| APD811 | EXPERIMENTAL | Multiple dose titration to maximum tolerated dose. |
| Placebo | PLACEBO_COMPARATOR | Multiple dose titration to maximum tolerated dose. |
| Name | Type | Description |
|---|---|---|
| APD811 | DRUG | - |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Males or females aged 18-75 years, inclusive * Symptomatic WHO Group 1 PAH classified by one of the following subgroups: * Idiopathic pulmonary arterial hypertension (IPAH); * Heritable pulmonary arterial hypertension (HPAH); * Drugs and toxins induced; * Associated p...