CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 166 enrolled
Drug / intervention
Bardoxolone methyl +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02036970
NCT02036970Phase 2Completed

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

Biogen·interventional·Posted Jan 15, 2014·Updated Jun 10, 2025

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.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 15, 2014
Enrollment StartMay 31, 2014
Primary CompletionJan 19, 2018
Study CompletionMay 16, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.5 years ago

Interventions

Bardoxolone methyldrug

Placebodrug