Pulmonary Arterial Hypertension
Conditions
Interventions
Patients will start dosing at 10 mg of bardoxolone methyl every other day, then
begin once dailydosing at Week 4. Dose de-escalation (down to 5 mg) is
permitted during the study, if indicated clinic
Extended Access Program
Pulmonary Hypertension
Sponsors
Reata Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. 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, 2. Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl, 3. 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, 4. Women who are pregnant or breastfeeding, 5. 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, 6. Known hypersensitivity to any component of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Frequency, intensity, and relationship to study drug of adverse events (AEs) and serious adverseevents (SAEs), and change from baseline in the following assessments: physical examinations, vital sign measurements, BNP, N-terminal pro-brain natriuretic peptide (NT-proBNP), and weight. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Germany, Israel, Mexico, Netherlands, Spain, United Kingdom, United States of America
Outcome results
None listed