NCT01847014

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

AC-055-402: 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	Macitentan tablet, dose of 10 mg, once daily.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-10-01
• Completion: 2017-11-30
• First posted: 2013-05-06
• Last updated: 2018-08-22
• Results posted: 2018-08-22

Locations

2 sites across 1 country: United States