Pulmonary Arterial Hypertension Clinical Trial
Official title:
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
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric
validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with
pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of
which they will receive macitentan, 10 mg, once daily.
The primary objectives are to demonstrate the final content validity of the PAH SYMPACT
instrument, to demonstrate the psychometric characteristics of reliability and construct
validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT
instrument to detect change. The secondary objective is to assess the safety of macitentan in
patients with pulmonary arterial hypertension. The exploratory objective is to explore the
effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in
patients with pulmonary arterial hypertension.
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