Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367770
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2006-08-21
Brief Title:
BREATHE 5-OL Tracleer Bosentan in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multi-Center Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer Bosentan in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
Status:
COMPLETED
Status Verified Date:
2016-07
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:
None
Brief Summary:
This 6-month open label study will evaluate the long term safety of bosentan via oxygen saturation and efficacy exercise capacity in patients who have completed the BREATHE-5 study PAH related to Eisenmenger physiology Treatment duration is 6 months
Detailed Description:
This is a multicenter open-label single -arm study with bosentan initial dose of 625 mg bid with a target dose of 125 mg bid All patients will be assessed for eligibility during the baseline visit same as Week 16 end of study BREATHE-5 visit and will have the option to enter into the open-label extension study at a starting dose of 625 mg bid for safety reasons Visit 2 is required as a safety visit to assess oxygen saturation SpO2 after 1 week of bosentan treatment Patients will return for Visit 4 after 4 weeks of treatment and the dose will be up-titrated to 125 mg bid or maintained at 625 mg bid at the judgement of the investigator Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues this extension study may be terminated at the sponsors request
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