Dataset from 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.

本项4期临床试验采用开放标签非对照研究设计是合理的，该试验旨在评估以波生坦（bosentan）为核心的治疗方案（单药治疗或联合西地那非）能否使肺动脉高压（PAH）患者在接受28周治疗后，达到6分钟步行距离（6MWD）≥380米的目标。该设计同样适用于率先探索心脏磁共振成像（cardiac MRI）在评估PAH患者功能能力改善中的应用价值，并探究其与其他临床参数的相关性。