Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02932410
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2016-10-12
Brief Title:
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension PAH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Open-label Randomized Study With Single-arm Extension Period to Assess the Pharmacokinetics Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
TOMORROW
Brief Summary:
This is a prospective multicenter open-label randomized controlled parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics PK safety and efficacy of macitentan in children with pulmonary arterial hypertension PAH
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