Condition/Intervention

• Pulmonary hypertension

Study Name

A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension

Phase

Phase 2

Summary

This study is designed to test the investigational use of a drug called bardoxolone methyl in patients with pulmonary arterial hypertension (PAH). Researchers will test the safety and effectiveness of bardoxolone methyl by evaluating how the drug influences exercise ability and PAH disease symptoms. In addition, the study will examine the effect of bardoxolone methyl on the function of the heart and blood vessels in the lungs.

Key Inclusion Criteria

• Adults at least 18 years old and less than or equal to 75 years of age
• Body mass index greater than 18.5 kg/m²
• Symptomatic pulmonary arterial hypertension
• Diagnostic right heart catheterization documented within 36 months that confirmed a diagnosis of PAH

Key Exclusion Criteria

• Participation in other investigational clinical studies involving pharmaceutical products being tested or used in a way different from the approved form or when used for an unapproved indication
• Initiation of an exercise program for cardio-pulmonary rehabilitation within three months prior or planned initiation during part one of the study
• Stopped receiving any PAH chronic therapy within 60 days prior to study

Please see complete list of inclusion and exclusion criteria.

Principal Investigator

Victor Tapson, MD

Co-Investigators

Antoine Hage, MD
Michael Lewis, MD

Study Coordinator and Contact

Lucy Garcia
Phone: 310-248-7134
Email: lucilla.garcia@cshs.org

Status

Active

IRB No.

37752

Date Last Updated

08/15