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Reata CTD with PAH - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn how safe a medicine called bardoxolone methyl is and how well it works in people with CTD-PAH. We will also look at how bardoxolone methyl will affect your ability to exercise and how well your symptoms improve.

What is the Condition Being Studied?

Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (CTD-PAH)

Who Can Participate in the Study?

Adults between 18 and 75 years of age who:
- Have not started an exercise program for cardio-pulmonary rehabilitation with 90 days before starting the study
- Don't have uncontrolled high blood pressure, history of Type 2 diabetes, chronic liver disease or atrial fibrillation

Age Group
Adults

What is Involved?

If you agree to join the study, you will:
- Be randomly assigned (like flip of a coin) to either placebo (a sugar pill) or a medicine called bardoxolone methyl
- Have a screening visit during which you will answer questions about your medical history, have study procedures including lab tests.
- Have a total of 9 study visits and you will be contacted by telephone several times throughout the study

Study Details

Full Title
A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION
Principal Investigator
Allergy & Immunology Specialist
Protocol Number
IRB:PRO00074526
NCT:NCT02657356
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698