Ignite Creation Date:
2024-05-06 @ 7:07 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02471183
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2015-06-11
Brief Title:
Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Multicenter Open-label Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2017-12
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:
TRANSIT-1
Brief Summary:
This study enrolls patients with pulmonary arterial hypertension PAH treated with inhaled treprostinil During the study the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment selexipag targeting the disease in a similar way The purpose of the study is i to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil ii to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition and iii to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil Study participants may stay in the study until the FDA has granted marketing authorization
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