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Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

NCT03068130 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2025-06-11

Study results available
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Summary

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Bardoxolone methyl

Capsules of Bardoxolone methyl

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2020-09-30
Completion
2020-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Israel
  • Japan
  • Mexico
  • Netherlands
  • Philippines
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03068130 on ClinicalTrials.gov