Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071461
Status:
COMPLETED
Last Update Posted:
2012-02-24
First Post:
2003-10-23
Brief Title:
Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
Actelion
Organization:
Actelion
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUILD 1
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BUILD 1 | None | None | None |