Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (SCOBA-PH)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension|
- Number of Subjects Not Able to Tolerate Ambrisentan [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: Yes ]If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.
- Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.
|Study Start Date:||May 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
Other Name: Letairis
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 ERA's, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330108
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||Robert C Bourge, MD||Univerisity of Alabama at Birmingham|