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NCT00903331 · ClinicalTrials.gov registry record · Phase 2

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

A Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by Actelion.

Completed
Registry status
Phase 2
Development phase
178
Enrollment target
20
Study locations

NCT00903331 is a Phase 2 study of Idiopathic Pulmonary Fibrosis that has completed, run by Actelion. The registered enrollment target is 178 participants, below the 748-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00903331, a Phase 2 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 2
Development phase
178 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Idiopathic Pulmonary Fibrosis

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

63 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, categorized as Phase 2. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 748-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (76% lower). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.

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.

NCT00903331 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Other, Arizona.

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.

What interventions are being tested in trial NCT00903331?

The interventions under investigation include: Placebo (DRUG), ACT-064992 (macitentan) (DRUG).

Who is sponsoring clinical trial NCT00903331?

This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.