ACT-293987 in Pulmonary Arterial Hypertension

• Status: Active, not recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Selexipag

Criteria

Inclusion Criteria:

• Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.

• Signed informed consent.

Exclusion Criteria:

• Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.

• Severe hepatic impairment (Child-Pugh C).

• Females who are pregnant or who plan to become pregnant during the study, or are breastfeeding.

• Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.