Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (SCOBA-PH)
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|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|
|Actual Primary Completion Date :||June 2012|
|Actual 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12 weeks ]If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start.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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|