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.
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. Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
261
Capsules of Bardoxolone methyl
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities.
Time frame: From time of first dose until the final visit, up to 172 weeks
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Banner University Medical Center, Phoenix Advanced Lung Disease Institute
Phoenix, Arizona, United States
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
...and 86 more locations