Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

• Status: Terminated
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: All

Summary

SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.

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

Details

• Lead Sponsor: Actelion
• Treatments: Macitentan

Criteria

Inclusion Criteria:

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

• Patients with PAH who completed study AC-055-401

• Women of childbearing potential must:

• Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.

• Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Exclusion Criteria:

• Patients who prematurely discontinued study drug in study AC-055-401

• Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study

• Known hypersensitivity to macitentan or its excipients or drugs of the same class