NCT02081690

A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain

A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study. Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish versions of the PAH-SYMPACT™. To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to detect change. Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial hypertension (PAH). Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.

Conditions

• Pulmonary Arterial Hypertension

Interventions

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

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2014-03-07
• Last updated: 2018-03-21
• Results posted: 2018-02-05

Locations

39 sites across 3 countries: France, Italy, Spain