Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319267
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2006-04-26
Brief Title:
Bosentan in Children With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
An Open Label Multicenter Study to Assess the Pharmacokinetics Tolerability and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2016-05
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:
FUTURE-1
Brief Summary:
The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension PAH or familial pulmonary arterial hypertension using a pediatric formulation is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population
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 |
|---|---|---|---|
| 2004-005157-63 | EUDRACT_NUMBER | None | None |