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Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

NCT00903331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2014-02-17

Study results available
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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.

Conditions

Interventions

DRUG

ACT-064992 (macitentan)

ACT-064992 (macitentan) tablet, 10 mg, once daily

DRUG

Placebo

matching placebo, once daily

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Loic Perchenet, Ph.D. · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903331 on ClinicalTrials.gov