Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2020-12-07
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

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

Details

• Lead Sponsor: Actelion
• Treatments: Macitentan

Criteria

Inclusion Criteria:

• Signed informed consent prior to initiation of any study-mandated procedure.

• Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.

• Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion Criteria:

• Any major violation of protocol AC 055 302/SERAPHIN.

• Pregnancy or breast-feeding.

• AST and/or ALT > 3 times the upper limit of the normal range.

• 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.

• Known hypersensitivity to ACT 064992 or any of the excipients.