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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: Completed Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by Actelion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient's measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00903331 record still lists
NCT00903331 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 748-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (76% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00903331's enrollment target sits among peer trials
178 15th of 51 higher than 37 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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