Combination Therapy in Pulmonary Arterial Hypertension

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.

Timeline

Start

2007-03

Primary completion

2010-05

Completion

2010-08

Publications

• Benza RL, Raina A, Gupta H, Murali S, Burden A, Zastrow MS, Park MH, Simon MA. Bosentan-based, treat-to-target therapy in patients with pulmonary arterial hypertension: results from the COMPASS-3 study. Pulm Circ. 2018 Jan-Mar;8(1):2045893217741480. doi: 10.1177/2045893217741480. Epub 2017 Oct 24.

Drugs

Indications