Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis
Public ClinicalTrials.gov record NCT00071461. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available. The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF. It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.
Study identification
- NCT ID
- NCT00071461
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 158 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2003 (Type not available)
- Primary completion
- Sep 2005 (Actual)
- Completion
- May 2010 (Actual)
- Last update posted
- Feb 24, 2012
2003 – 2010
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - Pulmonary Division | Birmingham | Alabama | 35294 | — |
| David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine | Los Angeles | California | 90024 | — |
| UCSD Medical Center | San Diego | California | 92103 | — |
| University of California - Ambulatory Care Center | San Francisco | California | 94143 | — |
| National Jewish Medical and Research Center | Denver | Colorado | 80204 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| University of Iowa Hospitals & Clinics - Department of Internal Medicine | Iowa City | Iowa | 52242 | — |
| University of Michigan Health System - Division of Pulmonary & Critical Care Medicine | Ann Arbor | Michigan | 48109 | — |
| Mayo Medical School - Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Washington - Division of Pulmonary & Critical Care Medicine | Seattle | Washington | 98195 | — |
| University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00071461, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2012 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00071461 live on ClinicalTrials.gov.