Last updated on April 2019

Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

Brief description of study

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

Detailed Study Description

This double-blind, randomized, placebo-controlled trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with WHO Group I CTD-PAH.

Qualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Patients randomized to placebo will remain on placebo throughout the study. Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4 unless contraindicated clinically. Dose de-escalation is permitted during the study if indicated clinically.

All patients in the study will follow the same visit and assessment schedule. Following randomization, patients will be scheduled to be assessed in person during treatment at Weeks 1, 2, 4, 6, 8, 16, and 24 and by telephone contact on Days 3, 10, 21, 31, 38, 84, and 140. Patients will also be scheduled to be assessed at an in person follow up visit at Week 28, four weeks after the end of treatment.

Clinical Study Identifier: NCT02657356

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Cedars Sinai Medical Center

Beverly Hills, CA United States
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Harbor - UCLA Medical Center

Torrance, CA United States
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University of Florida

Gainesville, FL United States
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Augusta University

Augusta, GA United States
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Piedmont-Georgia Lung

Austell, GA United States
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Cleveland Clinic

Cleveland, OH United States
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University of Pennsylvania

Philadelphia, PA United States
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Thomas Jefferson University

Philadelphia, PA United States
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University of Utah

Salt Lake City, UT United States
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Premier Clinical Research

Spokane, WA United States
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Aurora Health Care

Milwaukee, WI United States
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Fundaci n Favaloro

Buenos Aires, Argentina
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University of Cincinnati

Cincinnati, OH United States
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NYU Langone Health

New York, NY United States
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Hospital Cordoba

Cordoba, Argentina
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John Hunter Hospital

New Lambton, Australia
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UZ Leuven

Leuven, Belgium
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H pital Erasme

Brussels, Belgium
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Universit tsklinikum Freiburg

Freiburg im Breisgau, Germany
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Thorax Klinik

Heidelberg, Germany
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Cleveland Clinic Florida

Weston, FL United States
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University of Michigan

Ann Arbor, MI United States
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University of New Mexico

Albuquerque, NM United States
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Recruitment Status: Open

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