Trial · NCT00631475
Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
NCT00631475, Phase 3, Completed, Actelion; results first posted 2012-08-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443. Trials, record NCT00631475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00631475
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443
- NCT number
- NCT00631475
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 128 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Bosentan
- First posted
- 2008-03-07
- Last updated
- 2025-02-04
- Results first posted
- 2012-08-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Start of study to end of study, up to 21 months | Mean extent of exposure to bosentan treatment in months |
| Secondary | Number of Patients Exposed to Bosentan Over Time | Start to end of study, up to 21 months | Numbers of participants exposed to bosentan treatment over time |
| Secondary | Adverse Events (AE) Leading to Discontinuation of Study Drug. | Start to end of study, up to 21 months | Number of participants with at least one AE that led to permanent discontinuation of study treatment. |
| Secondary | Treatment-emergent Serious Adverse Events (SAE) | up to 21 months plus 28 days after the end of study drug | Number of participants with at least one SAE during the study. |
| Secondary | Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality. | up to 21 months, plus 24 hours after the end of study treatment | Number of participants with an increase in ALT and/or AST to \> 3 times upper limit of normal during the study. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Start of study to end of study, up to 21 months | For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of open label (OL) treatment. | months | MEAN |
| SECONDARY | Number of Patients Exposed to Bosentan Over Time | Start to end of study, up to 21 months | For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of OL treatment, respectively. | Participants | NUMBER |
| SECONDARY | Adverse Events (AE) Leading to Discontinuation of Study Drug. | Start to end of study, up to 21 months | Study population | participants | NUMBER |
| SECONDARY | Treatment-emergent Serious Adverse Events (SAE) | up to 21 months plus 28 days after the end of study drug | Study population | participants | NUMBER |
| SECONDARY | Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality. | up to 21 months, plus 24 hours after the end of study treatment | Study population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Bosentan Treatment | 6.4 | Standard Deviation 4.6 | months | |
| Number of Patients Exposed to Bosentan Over Time | Bosentan Treatment | For at least 4 months | 74 | Participants | |
| Number of Patients Exposed to Bosentan Over Time | Bosentan Treatment | For at least 8 months | 44 | Participants | |
| Number of Patients Exposed to Bosentan Over Time | Bosentan Treatment | For at least 12 months | 17 | Participants | |
| Number of Patients Exposed to Bosentan Over Time | Bosentan Treatment | For at least 16 months | 7 | Participants | |
| Number of Patients Exposed to Bosentan Over Time | Bosentan Treatment | For at least 20 months | 2 | Participants | |
| Adverse Events (AE) Leading to Discontinuation of Study Drug. | Bosentan Treatment | 32 | participants | ||
| Treatment-emergent Serious Adverse Events (SAE) | Bosentan Treatment | 51 | participants | ||
| Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality. | Bosentan Treatment | 3 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosentan Treatment | 128 | |
| Overall Study | COMPLETED | Bosentan Treatment | 83 | |
| Overall Study | NOT COMPLETED | Bosentan Treatment | 45 |
Source ClinicalTrials.gov
Adverse events47
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 | LIVER FUNCTION TEST ABNORMAL | Investigations | Bosentan Treatment | 2 | 128 | |
| other | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 1 | 128 | |
| other | IDIOPATHIC PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 1 | 128 | |
| other | OEDEMA PERIPHERAL | General disorders | Bosentan Treatment | 1 | 128 | |
| serious | Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 23 | 128 | |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 4 | 128 | |
| serious | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 3 | 128 | |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 1 | 128 | |
| serious | Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 1 | 128 | |
| serious | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Bosentan Treatment | 1 | 128 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosentan Treatment | ||
| Total, other adverse events | Bosentan Treatment | 5 | 128 |
| Total, serious adverse events | Bosentan Treatment | 51 | 128 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00631475
GET https://conductscience.org/api/trials/v1/NCT00631475/events?page=2