Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:9/21/2018
Start Date:April 18, 2017
End Date:December 2021
Contact:Lacey Powers
Email:ranger@reatapharma.com
Phone:(972) 865-2219

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An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension

This extended access study will assess the long-term safety and tolerability of bardoxolone
methyl in qualified patients with pulmonary hypertension (PH) who previously participated in
controlled clinical studies with bardoxolone methyl.

This extended access study will assess the long-term safety and tolerability of bardoxolone
methyl in qualified patients with pulmonary hypertension (PH) who previously participated in
controlled clinical studies with bardoxolone methyl.

Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is
available through commercial channels or until patient withdrawal, whichever is sooner. Dose
de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

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:

- 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;

- Patients who have an ongoing SAE from a clinical study that is assessed by the
investigator as related to bardoxolone methyl;

- 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;

- Women who are pregnant or breastfeeding;

- 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;

- Known hypersensitivity to any component of the study drug
We found this trial at
52
sites
Chapel Hill, North Carolina 27599
Principal Investigator: James Ford, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Richard Channick, MD
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Nicholas Hill, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Aaron Waxman, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Harrison W. Farber, MD
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Remzi Bag, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Kristin Highland, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Eric Greidinger, MD
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Principal Investigator: Roxana Sulica, MD
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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New York, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: John Ryan, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1000 W Carson St
Torrance, California 90502
Principal Investigator: Ronald J. Oudiz, MD
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Torrance, CA
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Franck Rahaghi, MD
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Albuquerque, New Mexico 87131
Principal Investigator: Lana Melendres, MD
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Albuquerque, NM
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Augusta, Georgia 30912
Principal Investigator: James Gossage, MD
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Augusta, GA
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13001 East 17th Place
Aurora, Colorado 80045
Principal Investigator: David Badesch, MD
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Aurora, CO
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3820 Medical Park Dr
Austell, Georgia 30106
Principal Investigator: Chad Miller, MD
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Austell, GA
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Beverly Hills, California 90211
Principal Investigator: Antoine Hage, MD
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Buenos Aires, Villa Vatteone
Principal Investigator: Andrea Medina, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Rahul Argula, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Chicago, Illinois 60611
Principal Investigator: Michael Cuttica, MD
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Chicago, IL
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Roberto Machado, MD
University of Illinois at Chicago A major research university in the heart of one of...
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Cincinnati, Ohio 45219
Principal Investigator: Peter Engel, MD
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Cincinnati, OH
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Nitin Bhatt, MD
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Sonja Bartolome, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Ankoor Shah, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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El Paso, Texas 79912
Principal Investigator: Adrian Casillas, MD
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El Paso, TX
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Houston, Texas 77030
Principal Investigator: Zeenat Safdar, MD
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7000 Fannin Street
Houston, Texas 77030
Principal Investigator: Namita Sood, MD
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Houston, Texas 77030
Principal Investigator: Maureen Mayes, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Leslie Spikes, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: David Poch, MD
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Justin Roberts, DO
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lancaster, PA
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Los Angeles, California 90073
Principal Investigator: Shelley Shapiro, MD
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Rajan Saggar, MD
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Louisville, Kentucky 40202
Principal Investigator: John McConnell, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Dianne Zwicke, MD
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Shilpa DeSouza, MD
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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1514 Jefferson Highway
New Orleans, Louisiana 70121
Principal Investigator: Stacy Mandras, MD
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New Orleans, LA
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New York, New York 10065
Principal Investigator: Evelyn Horn, MD
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Norfolk, Virginia 23507
Principal Investigator: Michael Eggert, MD
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Norfolk, VA
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Oklahoma City, Oklahoma 73120
Principal Investigator: John Kingrey, MD
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Oklahoma City, OK
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Harold Palevsky, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Michael Scharf, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85004
Principal Investigator: Rajeev Saggar, MD
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Phoenix, Arizona 85013
Principal Investigator: Jeremy Feldman, MD
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Therese Domsic, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Portland, Maine 04102
Principal Investigator: Joel Wirth, MD
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Portland, ME
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Rochester, New York 14642
Principal Investigator: Jim White, MD
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Sacramento, California 95817
Principal Investigator: Roblee Allen, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Murali Chakinala, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Shreveport, Louisiana 71130
Principal Investigator: Samina Hayat, MD
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Washington, District of Columbia 20007
Principal Investigator: Tunay Kuru, MD
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Washington,
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