Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01330108
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2011-04-04
Brief Title:
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2014-06
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:
SCOBA-PH
Brief Summary:
The primary objective of this study is to assess the safety and tolerance of changing patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension
Detailed Description:
The therapy of pulmonary arterial hypertension PAH has been revolutionized with the development and subsequent instruction of oral endothelin receptor antagonists ERA The first approved ERA bosentan Tracleer Actelion Inc is an effective drug widely used throughout the world in the therapy of PAH Newer ERAs with purported advantages over the first approved drug have since been tested and subsequently been approved for the therapy of PAH in the USA and other countries including ambrisentan Letairis Gilead Sciences Inc However there is little data available on the efficacy safety and tolerability of the elective change from oral bosentan to oral ambrisentan in PAH
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