Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

Summary

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

Timeline

Start

2016-10-04

Primary completion

2020-05-07

Completion

2020-05-07

Outcome

Missed primary endpoint

Stopped: “Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health”

registry analysis (superiority test); Placebo Capsules vs Bardoxolone Methyl Capsules; p = 0.0683; LS Mean difference (Net) -12.86 (95% CI -26.69 to 0.98) NCT02657356 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bardoxolone methyl	Small molecule	10 mg	Oral

Indications