Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03197688
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2017-05-12
Brief Title:
Retrospective Chart Review of First-time Opsumit Macitentan Users in the United States
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Multicenter Retrospective Chart Review of First-time Opsumit Macitentan Users in the United States
Status:
COMPLETED
Status Verified Date:
2018-09
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:
OrPHeUS
Brief Summary:
The Opsumit Users registry OPUS NCT02126943 was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period 5000 Opsumit new users by October 2018 The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size
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?:
False
Is an FDA AA801 Violation?:
None