Long-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension

Long-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL: Prostacyclin (PGI2) Receptor agonist In PAH Open Label

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41513

Enrollment

Registered

2010-06-04

Start date

2014-07-09

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Interventions

Each patient who has completed the double-blind study AC-065A302 as scheduled per protocol will be using selexipag (ACT-293987) at his/her individual highest tolerated dose. Dose: oral / tablet / tw

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Signed informed consent prior to initiation of any study-mandated procedure. - Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study). - Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after study drug discontinuation.

Exclusion criteria

Exclusion criteria: - Pediatric patients (i.e.,

Design outcomes

Primary

Measure	Time frame
No primary efficacy endpoint is considered for this open label extension study.	—

Secondary

Measure	Time frame
Safety and Tolerability endpoints: * Treatment-emergent AEs up to 3 days after study drug discontinuation. * Treatment-emergent SAEs up to 3 days after study drug discontinuation. * AEs leading to premature discontinuation of study drug.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)