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 |
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.
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.
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
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
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...
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Richard Channick, MD
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
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...
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
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...
Click here to add this to my saved trials
72 East Concord Street
Boston, Massachusetts 02118
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...
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
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...
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
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...
Click here to add this to my saved trials
1601 Northwest 12th Avenue
Miami, Florida 33136
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...
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
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...
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
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...
Click here to add this to my saved trials
1000 W Carson St
Torrance, California 90502
Torrance, California 90502
Principal Investigator: Ronald J. Oudiz, MD
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
Principal Investigator: Lana Melendres, MD
Click here to add this to my saved trials
Click here to add this to my saved trials
13001 East 17th Place
Aurora, Colorado 80045
Aurora, Colorado 80045
Principal Investigator: David Badesch, MD
Click here to add this to my saved trials
3820 Medical Park Dr
Austell, Georgia 30106
Austell, Georgia 30106
Principal Investigator: Chad Miller, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: Antoine Hage, MD
Click here to add this to my saved trials
Buenos Aires, Villa Vatteone
Principal Investigator: Andrea Medina, MD
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Principal Investigator: James Ford, MD
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
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...
Click here to add this to my saved trials
Chicago, Illinois 60611
Principal Investigator: Michael Cuttica, MD
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
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...
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
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...
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Zeenat Safdar, MD
Click here to add this to my saved trials
7000 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
Principal Investigator: Namita Sood, MD
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Maureen Mayes, MD
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
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...
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
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...
Click here to add this to my saved trials
555 N Duke St
Lancaster, Pennsylvania 17602
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...
Click here to add this to my saved trials
Los Angeles, California 90073
Principal Investigator: Shelley Shapiro, MD
Click here to add this to my saved trials
10833 Le Conte Ave
Los Angeles, California 90095
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...
Click here to add this to my saved trials
Louisville, Kentucky 40202
Principal Investigator: John McConnell, MD
Click here to add this to my saved trials
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
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,...
Click here to add this to my saved trials
1514 Jefferson Highway
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Principal Investigator: Stacy Mandras, MD
Click here to add this to my saved trials
Click here to add this to my saved trials
Norfolk, Virginia 23507
Principal Investigator: Michael Eggert, MD
Click here to add this to my saved trials
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
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...
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
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,...
Click here to add this to my saved trials
Phoenix, Arizona 85004
Principal Investigator: Rajeev Saggar, MD
Click here to add this to my saved trials
Phoenix, Arizona 85013
Principal Investigator: Jeremy Feldman, MD
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Therese Domsic, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
Click here to add this to my saved trials
Portland, Maine 04102
Principal Investigator: Joel Wirth, MD
Click here to add this to my saved trials
Rochester, New York 14642
Principal Investigator: Jim White, MD
Click here to add this to my saved trials
Sacramento, California 95817
Principal Investigator: Roblee Allen, MD
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
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...
Click here to add this to my saved trials
Shreveport, Louisiana 71130
Principal Investigator: Samina Hayat, MD
Click here to add this to my saved trials
Washington, District of Columbia 20007
Principal Investigator: Tunay Kuru, MD
Click here to add this to my saved trials