NCT00433329

Combination Therapy in Pulmonary Arterial Hypertension

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Bosentan	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
DRUG	Sildenafil	Oral sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2007-02-09
• Last updated: 2025-02-04
• Results posted: 2013-05-17