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

Stopped early · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT01847014

Run by

Actelion

People needed

4

Starts

2013-09-01

Expected to finish

2017-11-30

Last updated by the study team

2018-08-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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