At a glance
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A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
In Brief
A Phase 2 clinical trial evaluating Bardoxolone methyl and Placebo for Pulmonary Arterial Hypertension and 11 related conditions. Completed, enrolled 166 participants across 32 sites in 2 countries.
Detailed Summary
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation.