Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension bosentan sildenafil combination therapy Compass 3
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

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:

Arms:
arm 1: Oral bosentan 62.5 mg twice daily (BID) first 4 weeks, followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated, with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16

Interventions: intervention 1: Bosentan intervention 2: Sildenafil
Intervention descriptions: intervention 1: Oral bosentan 62.5 mg BID first 4 weeks followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated intervention 2: Oral sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16

Protocol document: