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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 is a Phase 2 study that has completed, run by Actelion. The registered enrollment target is 158 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00071461
The ClinicalTrials.gov registry entry for NCT00071461 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00071461 reports 0 study locations.
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.
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