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NCT00071461 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT00071461: Completed Phase 2 study, sponsored by Actelion.
NCT00071461 is a Phase 2 study that has completed, run by Actelion. The registered enrollment target is 158 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00071461, a Phase 2 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG bosentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2003-08 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT00071461 record still lists
NCT00071461 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00071461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00071461 about?
NCT00071461 is a clinical study titled "Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis". 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 t...
What is the current status of trial NCT00071461?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2003-08. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00071461?
The interventions under investigation include: Placebo (DRUG), bosentan (DRUG).
Who is sponsoring clinical trial NCT00071461?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00071461's enrollment target sits among peer trials
158 443rd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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