Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Actelion |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 100 |
| Start date | 2007-03 |
| Completion | 2010-08 |
Conditions
- Pulmonary Arterial Hypertension
Interventions
- Bosentan
- Sildenafil
Primary outcomes
- Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters — at 16 weeks and at 28 weeks of a stepped approach to therapy
The 6MWT is a non encouraged test, which measures the walking distance covered over a 6 minute period