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

Last updated: February 1, 2024
Sponsor: Reata, a wholly owned subsidiary of Biogen
Overall Status: Terminated

Phase

3

Condition

Chest Pain

Stress

Congestive Heart Failure

Treatment

Bardoxolone methyl

Clinical Study ID

NCT03068130
RTA 402-C-1602
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Treatment-compliant patients who are participating in qualifying ongoing studies andhave completed required End-of-Treatment and/or Follow-up visits in a prior clinicalstudy with bardoxolone methyl

Exclusion

Exclusion Criteria:

  • Participation in other investigational clinical studies involving interventionalproducts being tested or used in a way different from the approved form or when usedfor an unapproved indication;
  • Patients who have an ongoing SAE from a clinical study that is assessed by theinvestigator as related to bardoxolone methyl;
  • Unwilling to practice acceptable methods of birth control (both males who havepartners of childbearing potential and females of childbearing potential) while takingstudy drug;
  • Women who are pregnant or breastfeeding;
  • Patient is, in the opinion of the investigator, unable to comply with the requirementsof the study protocol or is unsuitable for the study for any reason;
  • Known hypersensitivity to any component of the study drug

Study Design

Total Participants: 261
Treatment Group(s): 1
Primary Treatment: Bardoxolone methyl
Phase: 3
Study Start date:
April 18, 2017
Estimated Completion Date:
September 30, 2020

Study Description

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.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Connect with a study center

  • Centro Médico Dra de Salvo

    Buenos Aires, Ciudad Autónoma De BuenosAires C1426ABP
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Mar Del Plata

    Buenos Aires, Mar Del Plata B7600FZN
    Argentina

    Site Not Available

  • Hospital Privado Centro Médico de Córdoba

    Cordoba, X5016KEH
    Argentina

    Site Not Available

  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Instituto Cardiovascular de Rosario

    Rosario, S2000DSR
    Argentina

    Site Not Available

  • Hospital Provincial Dr Jose Maria Cullen

    Santa Fe, S3000EPV
    Argentina

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton, New South Wales 2305
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • Hospital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Hospital de Messejana

    Fortaleza, Ceara 60864-190
    Brazil

    Site Not Available

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-074
    Brazil

    Site Not Available

  • Hospital Dia do Pulmão

    Blumenau, Santa Catarina 89010-000
    Brazil

    Site Not Available

  • Instituto do Coração - HCFMUSP

    São Paulo, 05403-900
    Brazil

    Site Not Available

  • Peter Lougheed Centre

    Calgary, Alberta T1Y 6J4
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université Laval

    Sainte Foy, Quebec G1V 4G5
    Canada

    Site Not Available

  • Hospital Las Higueras

    Talcahuano, 4270918
    Chile

    Site Not Available

  • Institut klinicke a experimentalni mediciny

    Prague, 140 00
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 00
    Czechia

    Site Not Available

  • Universitatsklinkum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • DRK Kliniken Berlin Westend

    Berlin, 14050
    Germany

    Site Not Available

  • Universitatsklinkum Carl Gustav Carus an der Tu

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Thorax Klinik

    Heidelberg, 69126
    Germany

    Site Not Available

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120
    Israel

    Site Not Available

  • Nazareth EMMS Hospital

    Nazareth, 16100
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, 49100
    Israel

    Site Not Available

  • ZIV Medical Center

    Safed, 13100
    Israel

    Site Not Available

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku 113-8603
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe, Hyogo 6500017
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara, Kanagawa 252-0375
    Japan

    Site Not Available

  • Kyorin University Hospital

    Tokyo, Mitaka-shi 181-8611
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama-shi, Okayama 701-1192
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya-shi, 467-8601
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, 0608648
    Japan

    Site Not Available

  • Kurume University Medical Center

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center

    Suita, 5658565
    Japan

    Site Not Available

  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez

    Ciudad de Mexico, Distrito Federal 14080
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Distrito Federal 14000
    Mexico

    Site Not Available

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco 44280
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Nuevo León, Monterrey 64460
    Mexico

    Site Not Available

  • Unidad de Investigación Clínica En Medicina SC

    Monterrey, Nuevo Leon 64718
    Mexico

    Site Not Available

  • Vrije Universiteit Amsterdam

    Amsterdam, Noord-Holland 1007 MB
    Netherlands

    Site Not Available

  • Philippine Heart Center

    Quezon City, Metro Manila 1100
    Philippines

    Site Not Available

  • Makati Medical Center

    Makati, 1229
    Philippines

    Site Not Available

  • Philippine General Hospital (PGH)

    Manila,
    Philippines

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda,
    Spain

    Site Not Available

  • Hospital Virgen de La Salud

    Toledo, 45004
    Spain

    Site Not Available

  • Golden Jubilee National Hospital

    Glasgow, G81 4HX
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Arizona Pulmonary Specialists

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Banner University Medical Center, Phoenix Advanced Lung Disease Institute

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • David Geffen School of Medicine UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • VA Healthcare System of Greater Los Angeles

    Los Angeles, California 90073
    United States

    Site Not Available

  • University of California Davis Medical Center - Division of Pulmonary and Critical Care

    Sacramento, California 95817
    United States

    Site Not Available

  • Harbor - UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • University of Colorado Denver - Division of Pulmonary Sciences

    Aurora, Colorado 80045
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Georgetown University Medical Center - Department of Rheumatology

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Georgetown University Medical Center - Department of Rheumatology

    Washington, D.C., District of Columbia 20007
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Cleveland Clinic of Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Piedmont-Georgia Lung

    Austell, Georgia 30106
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Ochsner Medical Center - Heart and Vascular Clinical Trials & Research Division

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Maine Medical Center - Division of Pulmonary and Critical Care Medicine

    Portland, Maine 04102
    United States

    Site Not Available

  • Boston University School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • University of Rochester - University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17603
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • BreatheAmerica El Paso

    El Paso, Texas 79902
    United States

    Site Not Available

  • The Methodist Hospital Research Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas - Health Science Center & Medical School at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Aurora Health Care

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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