Trial · NCT00391443
BUILD 3: Bosentan Use in Interstitial Lung Disease
NCT00391443, Phase 3, Completed, Actelion; results first posted 2012-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BUILD 3: Bosentan Use in Interstitial Lung Disease. Trials, record NCT00391443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BUILD 3: Bosentan Use in Interstitial Lung Disease
- NCT number
- NCT00391443
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 616 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Bosentan, Placebo
- First posted
- 2006-10-24
- Last updated
- 2025-02-04
- Results first posted
- 2012-05-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Occurrence of Disease Worsening or Death up to End of Study. | 36 months | Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF). |
| Secondary | Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. | 12 months | Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Occurrence of Disease Worsening or Death up to End of Study. | 36 months | The primary analysis was performed on the Intent To Treat (ITT) population. | participants with event | NUMBER |
| SECONDARY | Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. | 12 months | ITT population | percentage of participants with event | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Placebo | month 4 (122 days) | 10 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Bosentan | month 4 (122 days) | 18 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Placebo | month 8 (244 days) | 22 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Bosentan | month 8 (244 days) | 40 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Placebo | month12 (366 days) | 43 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Bosentan | month12 (366 days) | 74 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Placebo | month 18 (549 days) | 74 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Bosentan | month 18 (549 days) | 117 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Placebo | month 24 (732 days) | 88 | participants with event | |
| Time to Occurrence of Disease Worsening or Death up to End of Study. | Bosentan | month 24 (732 days) | 145 | participants with event |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 209 | |
| Overall Study | STARTED | Bosentan | 407 | |
| Overall Study | COMPLETED | Placebo | 209 | |
| Overall Study | COMPLETED | Bosentan | 407 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Bosentan | 0 |
Source ClinicalTrials.gov
Adverse events322
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 59 | 209 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Bosentan | 114 | 406 | |
| other | IDIOPATHIC PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | Placebo | 59 | 209 | |
| other | IDIOPATHIC PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | Bosentan | 92 | 406 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Placebo | 51 | 209 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Bosentan | 78 | 406 | |
| other | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Placebo | 24 | 209 | |
| other | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Bosentan | 57 | 406 | |
| other | FATIGUE | General disorders | Placebo | 15 | 209 | |
| other | FATIGUE | General disorders | Bosentan | 46 | 406 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Bosentan | ||
| Total, other adverse events | Placebo | 200 | 209 |
| Total, other adverse events | Bosentan | 386 | 406 |
| Total, serious adverse events | Placebo | 74 | 209 |
| Total, serious adverse events | Bosentan | 129 | 406 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21474646 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bosentan vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00391443
GET https://conductscience.org/api/trials/v1/NCT00391443/events?page=2