Table 2.
Recently completed, ongoing, and planned placebo-controlled studies including an event-driven assessment of morbidity and mortality as the primary end point
| Study name | Study drug(s) | Primary end point | Anticipated exposure (patient-years) |
|---|---|---|---|
| Studies using currently available PAH-specific therapies | |||
| AMBITION (NCT01178073) | First-line ambrisentan, tadalafil, or combination of both | Time to clinical failure | Study terminated when 105 events occurred; anticipated median treatment duration = 2.0 years; estimated total study duration = 2.75 years |
| COMPASS-2 (NCT00303459) | Addition of bosentan to baseline sildenafil | Time to first (adjudicated) morbidity/mortality event | Enrollment between 2006 and first quarter 2013 |
| Studies investigating novel agents for PAH | |||
| SERAPHIN (NCT00660179) | Macitentan | Time to first (adjudicated) morbidity/mortality event | 742 patients enrolled. |
| GRIPHON (NCT01106014) | Selexipag | Time to morbidity or mortality event (according to the definition of the Dana Point Fourth World Symposium on Pulmonary Hypertension) | Estimated to be up to 4.3 years |
| FREEDOM-Ev (NCT01560624) | Early addition of oral treprostinil to PDE-5i or ERA. | Time to first clinical worsening event | Clinical worsening assessed for up to 2.5 years |
Note
ERA, endothelin receptor antagonist; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase type 5 inhibitor.