Viewing Study NCT02126943



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Last Modification Date: 2024-10-26 @ 11:23 AM
Study NCT ID: NCT02126943
Status: COMPLETED
Last Update Posted: 2020-08-13
First Post: 2014-04-29

Brief Title: OPsumit USers Registry
Sponsor: Actelion
Organization: Actelion

Study Overview

Official Title: US-based Observational Drug Registry of Opsumit Macitentan New Users in Clinical Practice
Status: COMPLETED
Status Verified Date: 2020-08
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: OPUS
Brief Summary: Prospective observational drug registry developed to characterize the safety profile including primarily potential serious hepatic risks and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting
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