Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01389856
Status:
TERMINATED
Last Update Posted:
2015-05-01
First Post:
2011-06-30
Brief Title:
Persistent Pulmonary Hypertension of the Newborn
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Multicenter Double-blind Placebo-controlled Randomized Prospective Study of Bosentan as Adjunctive Therapy to Inhaled Nitric Oxide in the Management of Persistent Pulmonary Hypertension of the Newborn PPHN
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
To be compliant with the timelines as agreed with Paediatric Committee PC within the Paediatric Investigational Plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUTURE 4
Brief Summary:
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns PPHN is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites
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