Condition: Pulmonary arterial hypertension
Key Inclusion Criteria
- ≥18 to ≤75 years old
- Body mass index >18.5 kg/m2
- Symptomatic pulmonary hypertension
- World Health Organization Group I pulmonary arterial hypertension associated with connective tissue disease
Key Exclusion Criteria
- Participation in other studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1 of the study
- Started an exercise program for cardiopulmonary rehabilitation within 90 days prior to Day 1 or planned initiation during the study
- Stopped receiving any PAH chronic therapy within 60 days prior to Day 1
Full Study Name
A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (IRB no. 45718)
The purpose of this study is to determine the safety and effectiveness of oral (given by mouth) bardoxolone methyl in individuals with pulmonary arterial hypertension (PAH) associated with connective tissue disease (CTD-PAH). To assess the effectiveness of the drug, researchers will evaluate how bardoxolone methyl affects exercise ability and measures of clinical improvement. Researchers will also observe how bardoxolone methyl affects selected measures of clinical worsening and other CTD-PAH disease symptoms. To evaluate safety, the study will monitor vital signs, laboratory assessments and ECGs, in addition to tracking any adverse events that may be experienced.
The use of bardoxolone methyl is investigational; the effects of the drug will be compared against the effects of a placebo (inactive substance) on CTD-PAH.