Ignite Creation Date:
2024-05-05 @ 10:59 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01223352
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2010-10-12
Brief Title:
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
An Open-label Prospective Multicenter Study to Assess the Pharmacokinetics Tolerability Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2017-11
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 3
Brief Summary:
The primary objective of AC-052-373 was to assess the pharmacokinetic PK profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension PAH 12 years of age
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None