Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT

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.

Timeline

Start

2014-05-31

Primary completion

2018-01-19

Completion

2018-05-16

Outcome

Missed primary endpoint

registry p = 0.8133; Mean Difference (Net) -1.74 (95% CI -16.22 to 12.74) NCT02036970 ↗

Drugs

Indications