Overview

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