drugset / Trial / NCT01847014

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

NCT01847014

Phase 3 Terminated 4 enrolled Actelion
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-09-01
Primary completion
2015-10-01
Completion
2017-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Macitentan Other / unclassified 10 mg