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

Stopped early · Phase 3

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT03068130

Run by

Biogen

People needed

261

Starts

2017-04-18

Expected to finish

2020-09-30

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl

You may not qualify if…

• Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication;
• Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
• Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug;
• Women who are pregnant or breastfeeding;
• Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
• Known hypersensitivity to any component of the study drug

Where it is running

• Arizona Pulmonary Specialists — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Beverly Hills, California, United States
• University of California San Diego — La Jolla, California, United States
• VA Healthcare System of Greater Los Angeles — Los Angeles, California, United States
• David Geffen School of Medicine UCLA — Los Angeles, California, United States
• University of California Davis Medical Center - Division of Pulmonary and Critical Care — Sacramento, California, United States
• Harbor - UCLA Medical Center — Torrance, California, United States
• University of Colorado Denver - Division of Pulmonary Sciences — Aurora, Colorado, United States
• Georgetown University Medical Center - Department of Rheumatology — Washington D.C., District of Columbia, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Cleveland Clinic of Florida — Weston, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Piedmont-Georgia Lung — Austell, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Maine Medical Center - Division of Pulmonary and Critical Care Medicine — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Banner University Medical Center, Phoenix Advanced Lung Disease Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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