ACT-293987 in Pulmonary Arterial Hypertension

Actelion Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: ACT-293987

Study type

Interventional

Funder types

Industry

Identifiers

NCT01112306

AC-065A303

2009-014992-31 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment

709 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.