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COMPLETED Phase 2

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

NCT00903331 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG ACT-064992 (macitentan)

Study Locations (20)

California

  • U.C. Davis University of California — Sacramento
  • UCSD Pulmonary Critical Care — San Diego
  • University of California - San Francisco — San Francisco
  • Stanford University Medical Center - Chest Clinic — Stanford

Other

  • Prince Charles Hospital Lung Transplant — Chermside
  • St. Vincent's Public Hospital — Darlinghurst
  • The Alfred Hospital — Melbourne
  • Royal Perth Hospital — Perth

Arizona

  • Pulmonary Associates, P.A. — Phoenix
  • Mayo Clinic - Arizona — Scottsdale

Alabama

  • University of Alabama at Birmingham — Birmingham

Colorado

  • National Jewish Medical & Research Center — Denver

Connecticut

  • Yale University School of Medicine — New Haven

Kansas

  • Wichita Clinic P.A — Wichita

Missouri

  • St. Luke's Medical Group — Chesterfield

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2009-05
Est. Completion 2011-08
Phase Phase 2

Sponsor

Actelion

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00903331

The ClinicalTrials.gov registry entry for NCT00903331 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00903331 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Other, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00903331 about?

NCT00903331 is a clinical study titled "Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study". 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 plac...

What is the current status of trial NCT00903331?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2009-05. Estimated completion is 2011-08.

What conditions does trial NCT00903331 study?

This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00903331?

The interventions under investigation include: Placebo (DRUG), ACT-064992 (macitentan) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00903331?

This trial is sponsored by Actelion, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00903331 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial