Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (SCOBA-PH)
|ClinicalTrials.gov Identifier: NCT01330108|
Recruitment Status : Completed
First Posted : April 6, 2011
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: ambrisentan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension|
|Study Start Date :||May 2011|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
U.S. FDA Resources
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
Other Name: Letairis
- Number of Subjects Not Able to Tolerate Ambrisentan [ Time Frame: baseline to 12 weeks ]If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start.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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|