Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433329
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2007-02-07
Brief Title:
Combination Therapy in Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
COMPASS 3 An Open-label Multi-Center Study Employing a Targeted 6-Minute Walk Test 6-MWT Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging MRI on Cardiac Remodeling
Status:
COMPLETED
Status Verified Date:
2013-05
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:
COMPASS 3
Brief Summary:
An open label non-comparative study design is appropriate for this Phase 4 study designed to assess whether a core therapy of bosentan either as monotherapy or with the addition of sildenafil enables patients with pulmonary arterial hypertension PAH to achieve a 6-minute walk distance 6 MWD of 380 meters after 28 weeks of therapy This design is also appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity in PAH and exploring its correlation with other parameters
Detailed Description:
None
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