NCT00903331

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

Detailed description

The study included two treatment periods: Period 1 (fixed duration) from randomization up to the primary endpoint evaluation (Month 12 or earlier in case of premature discontinuation of study drug) and Period 2 (variable duration) from the primary endpoint evaluation visit up to the end of study (EOS). EOS occurred when the last patient randomized and not prematurely discontinued completed Period 1.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	ACT-064992 (macitentan)	ACT-064992 (macitentan) tablet, 10 mg, once daily
DRUG	Placebo	matching placebo, once daily

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2009-05-18
• Last updated: 2014-02-17
• Results posted: 2014-02-17

Locations

53 sites across 12 countries: United States, Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey (Türkiye)