Study:
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
Rationale:
n/a
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Pulmonary Arterial Hypertension |
Drug: Bosentan
Drug: Sildenafil |
Phase 4 |
Verified by
Actelion
May, 2013
Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov identifier: NCT00433329
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Florida
Weston, Florida 33331
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
n/a