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

Actelion Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: Macitentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01847014

AC-055-402

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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