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Bardoxolone Methyl in Patients With Pulmonary Arterial Hypertension
||A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Arterial Hypertension
||Nicholas Hill, MD
||Karen Visnaw, RN
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 16 weeks of study participation.
This is a two-part study.
Part 1: Part 1 of the study will include both dose-escalation and expansion cohorts.
Part 2 (extension period): All patients from Part 1 who complete the 16-week treatment period as planned will be eligible to continue directly into the extension period to evaluate the intermediate and long-term safety and efficacy of bardoxolone methyl.
- One of the following subtypes of WHO Group 1 PAH:
- Idiopathic or heritable PAH;
- PAH associated with connective tissue disease;
- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair;
- PAH associated with anorexigens;
- PAH associated with human immunodeficiency virus (HIV);
- Had a diagnostic right heart catheterization performed and documented within 12 months prior to Screening that confirmed a diagnosis of PAH
- Has been receiving an oral, disease-specific PAH therapy consisting of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type-5 inhibitor (PDE5i). PAH therapy must be at a stable dose for at least 90 days prior to Day 1;
- Receiving chronic treatment with a prostacyclin/prostacyclin analogue or riociguat within 60 days prior to Day 1. Use of prostacyclin for acute vasodilator testing during right heart catheterization is allowed;
- Requirement for receipt of intravenous inotropes within 30 days prior to Day 1;
- Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during Screening after a period of rest;
- A Physical examination will be performed
- Your vital signs will be taken (height, weight, blood pressure, temperature and heart rate)
- An EKG (a record of your heartbeat) will be performed
- Your medical history and current illnesses will be reviewed
- Your current medications will be reviewed
- Measurement of your exercise capacity (6 Minute Walk Test)
- Evaluation of your shortness of breath (the Borg Scale)
- Blood samples will be drawn for routine chemistry, Hepatitis B and C, biomarkers in your blood,and hematology testing. A pregnancy test will be performed from the blood drawn if you are a woman of childbearing potential
- Urine samples will be collected for routine testing
- Your demographic information will be collected(your age, gender and race)
- An Echocardiogram (an ultrasound of your heart) will be performed
- Your lung function will be tested (pulmonary function test: PFT) only if you have not had them done within 90 days of your Day 1 study visit
- You will have a 24 hour blood pressure monitoring device attached to you