Lariat (Reata 402-C-1302)

A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Arterial Hypertension

Lariat (Reata 402-C-1302) [NCT02036970]

Description: This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 16 weeks of study participation.

Drug: Bardoxolone methyl; Drug: Placebo

Primary Investigator: Engel

Drug/Device Information
To evaluate the safety, tolerability, and efficacy of Bardoxolone methyl in PAH
Oleanolic acid-derived synthetic triterpenoid compound that potently induces the Nrf2-Keap1 pathway with potential relevance in oxidative stress and inflammation
Randomized 3:1 to Bardoxolone methyl dose-escalation or placebo for 16 weeks followed by open label extension period
Reata Pharmaceuticals, Inc.
Major Inclusion and Exclusion
Age ≥ 18 to ≤ 75
WHO Group 1, III, V-sarcoid PAH
BMI > 18.5
Mean pulmonary artery pressure ≥ 25, PCWP ≤ 15 and PVR > 240
6-min. walk ≥ 150 meters
For WHO Group I PH patients with connective tissue disease, total lung capacity ≥ 65% (predicted)
For all other WHO Group I PH patients FEV1 ≥ 65% (predicted)
For WHO Group III or V PH patients, total lung capacity (TLC) between 50 - 90%
No eGFR ≥ 45
No history of obstructive sleep apnea that is untreated