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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02657356
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension Drug: Placebo capsules Drug: Bardoxolone methyl capsules Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Placebo Comparator: Placebo capsules
Placebo capsules will be administered orally once a day for 24 weeks.
Drug: Placebo capsules
Experimental: Bardoxolone methyl capsules
Bardoxolone methyl capsules will be administered orally once a day for 24 weeks. Starting dosage is 5 mg and will dose-escalate to 10 mg at Week 4, unless contraindicated clinically.
Drug: Bardoxolone methyl capsules
Other Name: RTA 402 capsules

Primary Outcome Measures :
  1. Change from baseline in six-minute-walk distance (6MWD) [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI > 18.5 kg/m2;
  • Symptomatic pulmonary hypertension WHO/NYHA FC class II and III;
  • WHO Group I PAH associated with connective tissue disease;
  • Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PAH according to all the following criteria:

    • Mean pulmonary artery pressure ≥ 25 mm Hg (at rest);
    • Pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg;
    • Pulmonary vascular resistance > 240 dyn.sec/cm5 or > 3 mm Hg/liter (L)/minute;
  • Has BNP level ≤ 400 pg/mL;
  • Had an average 6MWD ≥ 150 meters on two consecutive tests performed on different days prior to randomization, with both tests measuring within 15% of one another;
  • Has been receiving no more than two (2) approved disease-specific PAH therapies. PAH therapy must have been at a stable dose for at least 90 days prior to Day 1. No additions or changes should be made to PAH therapies and doses should remain stable for the duration of the study;
  • Has maintained a stable dose for 30 days prior to Day 1 if receiving any of the following therapies that may affect PAH: vasodilators (including calcium channel blockers), digoxin, L-arginine supplementation, or oxygen supplementation. No additions or changes should be made to therapies and doses should remain stable for the duration of the study;
  • If receiving treatment for CTD with prednisone or any other drugs, doses must remain stable for at least 30 days prior to Day 1 and for the duration of the study Had pulmonary function tests (PFTs) within 90 days prior to Day 1 with total lung capacity ≥ 65% (predicted);
  • Had a ventilation-perfusion (V/Q) lung scan, spiral/helical/electron beam computed tomography (CT), or pulmonary angiogram prior to Day 1 that shows no evidence of thromboembolic disease (i.e., should note normal or low probability for pulmonary embolism). If V/Q scan was abnormal (i.e., results other than normal or low probability), then a confirmatory CT or selective pulmonary angiography must exclude chronic thromboembolic pulmonary hypertension;
  • Has adequate kidney function defined as an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 as measured by the central lab;
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any patient-mandated procedures

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 within 30 days prior to Day 1;
  • Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day 1 or planned initiation during the study;
  • Stopped receiving any PAH chronic therapy within 60 days prior to Day 1;
  • Received a dose of prednisone > 20 mg/day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1;
  • Received intravenous (iv) or subcutaneous (sc) prostacyclin/prostacyclin analogues within 90 days prior to Day 1;
  • Received 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 BP > 100 mm Hg during Screening after a period of rest;
  • Has systolic BP < 90 mm Hg during Screening after a period of rest;
  • Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:

    • Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension;
    • Pericardial constriction;
    • Restrictive or congestive cardiomyopathy;
    • Left ventricular ejection fraction < 40% per echocardiogram (ECHO) within 90 days of Day 1;
    • Symptomatic coronary artery disease within the last 3 years;
  • Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment;
  • Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction:

    • Age > 65 years;
    • BMI ≥ 30 kg/m2;
    • History of systemic hypertension;
    • History of type 2 diabetes;
    • History of atrial fibrillation;
    • History of atrial septostomy within 180 days prior to Day 1;
    • History of uncontrolled obstructive sleep apnea;
  • Has a history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication) defined as mild to severe hepatic impairment (Child-Pugh Class A-C);
  • Serum aminotransferase (ALT or AST) levels > 1.5X the upper limit of normal (ULN) at Screening;
  • Hemoglobin (Hgb) concentration < 8.5 g/dL at Screening;
  • Diagnosis of Down syndrome;
  • History of malignancy within 5 years prior to screening, with the exception of localized skin or cervical carcinomas;
  • Untreated or uncontrolled active bacterial, fungal, or viral infection;
  • Known or suspected active drug or alcohol abuse, per investigator judgment;
  • Use of Herbalife supplements within 14 days prior to Day 1;
  • Major surgery within 30 days prior to Day 1 or planned to occur during the course of the study;
  • Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
  • Use of inhaled nitric oxide within 7 days prior to Screening and Day 1 visits, excluding acute vasodilator testing during diagnostic cardiac catheterization;
  • Women who are pregnant or breastfeeding;
  • Any disability or impairment that would prohibit performance of the 6MWT;
  • Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment;
  • 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;
  • Unable to communicate or cooperate with the investigator because of language problems, poor mental development, or impaired cerebral function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02657356

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United States, Arizona
Banner University Medical Center, Phoenix Advanced Lung Disease Institute Recruiting
Phoenix, Arizona, United States, 85004
Contact: Research Coordinator    602-839-0427      
Principal Investigator: Rajeev Saggar, MD         
Arizona Pulmonary Specialists Recruiting
Phoenix, Arizona, United States, 85012
Contact: Research Coordinator    602-271-0832      
Principal Investigator: Jeremy Feldman, MD         
United States, California
Cedars Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Research Coordinator    310-248-7134      
Principal Investigator: Antoine Hage, MD         
Regents of The University of California Recruiting
Fresno, California, United States, 93701
Contact: Research Coordinator    559-499-6637      
Principal Investigator: Vijay Balasubramanian, MD         
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Research Coordinator    858-657-7122      
Principal Investigator: David Poch, MD         
David Geffen School of Medicine UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Research Coordinator    310-794-3299      
Principal Investigator: Rajan Saggar, MD         
University of California Davis Medical Center - Division of Pulmonary and Critical Care Withdrawn
Sacramento, California, United States, 95817
Pacific Pulmonary Research, Inc. Recruiting
San Diego, California, United States, 92103
Contact: Research Coordinator    619-269-1652      
Principal Investigator: David Riker, MD         
Santa Barbara Pulmonary Associates Recruiting
Santa Barbara, California, United States, 93105
Contact: Research Coordinator    805-898-8840 ext 132      
Principal Investigator: Jeffrey Sager, MD         
Harbor - UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Research Coordinator    310-222-2515      
Principal Investigator: Ronald J. Oudiz, MD         
United States, District of Columbia
Georgetown University Medical Center - Department of Rheumatology Recruiting
Washington, District of Columbia, United States, 20007
Contact: Research Coordinator    202-444-6210      
Principal Investigator: Tunay Kuru, MD         
United States, Florida
University of Florida Withdrawn
Gainesville, Florida, United States, 32610
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Research Coorindator    305-243-8567      
Principal Investigator: Eric Greidinger, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Research Coordinator    954-659-6213      
Principal Investigator: Franck Rahaghi, MD         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Research Coordinator    706-721-6789      
Principal Investigator: James Gossage, MD         
Piedmont-Georgia Lung Recruiting
Austell, Georgia, United States, 30106
Contact: Research Coordinator    770-745-1404 ext 6      
Principal Investigator: Chad Miller, MD         
United States, Illinois
Northwestern Medical Faculty Foundation Withdrawn
Chicago, Illinois, United States, 60611
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Research Coordinator    312-355-5934      
Principal Investigator: Dustin Fraidenburg, MD         
United States, Kansas
University of Kansas Medical Center Withdrawn
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Research Coordinator    502-587-8000      
Principal Investigator: John McConnell, MD         
United States, Louisiana
Louisiana State University Health Sciences Center Withdrawn
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Research Coordinator    617-726-7935      
Principal Investigator: Flavia Castelino, MD         
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Research Coordinator    617-638-4475      
Principal Investigator: Elizabeth Klings, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Research Coordinator    734-936-5383      
Principal Investigator: Vallerie McLaughlin, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Research Coordinator    314-747-8174      
Principal Investigator: Murali Chakinala, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Research Coordinator    402-559-9580      
Principal Investigator: Tammy Wichman, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Research Coordinator    505-272-2273      
Principal Investigator: Lana Melendres, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10003
Contact: Research Coordinator    212-844-8824      
Principal Investigator: Roxana Sulica, MD         
University of Rochester - University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Research Coordinator    585-486-0869      
Principal Investigator: Jim White, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Research Coordinator    919-684-6150      
Principal Investigator: Ankoor Shah, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Research Coordinator    513-558-3077      
Principal Investigator: Jean Elwing, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Research Coordinator    216-444-2140      
Principal Investigator: Kristin Highland, MD         
Wexner Medical Center at The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Research Coordinator    614-366-2258      
Principal Investigator: Veronica Franco, MD         
United States, Oklahoma
Integris Nazih Zuhdi Transplant Institute Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Research Coordinator    405-713-4413      
Principal Investigator: John Kingrey, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Research Coordinator    503-494-9443      
Principal Investigator: Akram Khan, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Research Coordinator    215-294-9759      
Principal Investigator: Harold Palevsky, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Research Coordinator    215-955-8184      
Principal Investigator: Michael Scharf, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Research Coordinator    843-792-4349      
Principal Investigator: Rahul Argula, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Research Coordinator    214-645-6493      
Principal Investigator: Sonja Bartolome, MD         
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Research Coordinator    713-363-7536      
Principal Investigator: Zeenat Safdar, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Research Coordinator    713-500-6851      
Principal Investigator: Namita Sood, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Research Coordinator    801-585-2944      
Principal Investigator: John Ryan, MD         
United States, Virginia
Sentara Cardiovascular Research Institute Withdrawn
Norfolk, Virginia, United States, 23507
United States, Washington
Premier Clinical Research Withdrawn
Spokane, Washington, United States, 99202
United States, Wisconsin
Aurora Health Care Withdrawn
Milwaukee, Wisconsin, United States, 53215
Fundación Favaloro Active, not recruiting
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1093AAS
Hospital Británico de Buenos Aires Active, not recruiting
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1280AEB
Centro Médico Dra de Salvo Active, not recruiting
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1426ABP
Instituto de Investigaciones Clínicas Mar Del Plata Active, not recruiting
Buenos Aires, Mar Del Plata, Argentina, B7600FZN
Instituto De Enfermedades Respiratorias E Investigacion Medica Active, not recruiting
Buenos Aires, Villa Vatteone, Argentina, B1853AIK
Hospital Cordoba Active, not recruiting
Cordoba, Argentina, X5004CDP
Hospital Privado Centro Médico de Córdoba Active, not recruiting
Cordoba, Argentina, X5016KEH
Instituto de Cardiologia de Corrientes Juana Francisca Cabral Active, not recruiting
Corrientes, Argentina, W3400AMZ
Hospital de Alta Complejidad "Pte. J. D. Perón" Active, not recruiting
Formosa, Argentina, 3600
Australia, New South Wales
Royal Prince Alfred Hospital Active, not recruiting
Camperdown, New South Wales, Australia, 2050
St Vincent's Hospital Sydney Active, not recruiting
Darlinghurst, New South Wales, Australia, 2010
John Hunter Hospital Active, not recruiting
New Lambton, New South Wales, Australia, 2305
Australia, Queensland
Princess Alexandra Hospital Active, not recruiting
Brisbane, Queensland, Australia, 4102
Australia, Tasmania
Royal Hobart Hospital Active, not recruiting
Hobart, Tasmania, Australia, 7000
UZ Leuven Active, not recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Hôpital Erasme Active, not recruiting
Brussels, Belgium, 1070
Hospital de Messejana Active, not recruiting
Fortaleza, Ceara, Brazil, 60864-190
Irmandade Da Santa Casa de Misericordia de Porto Alegre Active, not recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
Hospital Dia do Pulmão Active, not recruiting
Blumenau, Santa Catarina, Brazil, 89010-000
Hospital São Paulo Active, not recruiting
Sao Paulo, Brazil, 04023-900
Instituto do Coração - HCFMUSP Active, not recruiting
São Paulo, Brazil, 05403-900
Canada, Alberta
Peter Lougheed Centre Active, not recruiting
Calgary, Alberta, Canada, T1Y 6J4
University of Alberta Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5W9
Canada, Quebec
Centre Hospitalier de l'Université Laval Active, not recruiting
Sainte Foy, Quebec, Canada, G1V 4G5
Centro de Investigación Clínica de la Universidad Católica Withdrawn
Santiago, Región-MetropolitanadeSantiago, Chile, 8330024
Hospital Las Higueras Withdrawn
Talcahuano, Chile, 4270918
Vseobecna fakultni nemocnice v Praze Active, not recruiting
Prague, Czechia, 128 00
Institut klinicke a experimentalni mediciny Active, not recruiting
Prague, Czechia, 140 00
Universitätsklinikum Freiburg Active, not recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Universitatsklinkum Erlangen Active, not recruiting
Erlangen, Bayern, Germany, 91054
Universität Greifswald Active, not recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
DRK Kliniken Berlin Westend Active, not recruiting
Berlin, Germany, 14050
Universitätsklinikum Carl Gustav Carus an der TU Dresden Active, not recruiting
Dresden, Germany, 01307
Universitätsklinikum Hamburg Eppendorf Active, not recruiting
Hamburg, Germany, 20246
Thorax Klinik Active, not recruiting
Heidelberg, Germany, 69126
Universitätsklinikum Köln Active, not recruiting
Köln, Germany, 50937
Hadassah University Hospital Ein Kerem Active, not recruiting
Jerusalem, Israel, 91120
Nazareth EMMS Hospital Withdrawn
Nazareth, Israel, 16100
Rabin Medical Center Active, not recruiting
Petah Tikva, Israel, 49100
ZIV Medical Center Withdrawn
Safed, Israel, 13100
Nippon Medical School Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8603
Contact: Research Coordinator    +81338222131      
Principal Investigator: Yuichiro Shirai, MD         
Hokkaido University Hospital Withdrawn
Sapporo, Hokkaido, Japan, 060-8648
Kitasato University Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0375
Contact: Research Coordinator    +427788111      
Principal Investigator: Sumiaki Tanaka, MD         
Kyorin University Hospital Withdrawn
Tokyo, Mitaka-shi, Japan, 181-8611
Tohoku University Hospital Recruiting
Sendai, Miyagi, Japan, 980-8574
Contact: Research Coordinator    +81227177056      
Principal Investigator: Koichiro Sugimura, MD         
National Hospital Organization Okayama Medical Center Recruiting
Okayama-shi, Okayama, Japan, 701-1192
Contact: Research Coordinator    +81862949519      
Principal Investigator: Hiromi Matsubara, MD         
Tokyo Women's Medical University Hospital Withdrawn
Tokyo, Shinjuku-ku, Japan, 162-0054
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Contact: Research Coordinator    +81432227171      
Principal Investigator: Seiichiro Sakao, MD         
Gunma University School of Medicine Recruiting
Gunma, Japan, 371-8510
Contact: Research Coordinator         
Principal Investigator: Noriaki Tanaka, MD         
Kobe University Hospital Recruiting
Kobe, Japan, 6500017
Contact: Research Coordinator    +81783825111      
Principal Investigator: Tu Taniguchi, MD         
Nagoya City University Hospital Withdrawn
Nagoya-shi, Japan, 467-8601
Nagoya Medical Center Recruiting
Nagoya, Japan, 460-0001
Contact: Research Coordinator         
Principal Investigator: Masao Katayama, MD         
Hokkaido University Hospital Recruiting
Sapporo, Japan, 0608648
Contact: Research Coordinator    +81117161161      
Principal Investigator: Ichizo Tsujino, MD         
Kurume University Medical Center Recruiting
Sendai-shi, Japan, 980-8574
Contact: Research Coordinator    +8888888888      
Principal Investigator: Yoshihiro Fukumoto, MD         
National Cerebral and Cardiovascular Center Recruiting
Suita, Japan, 5658565
Contact: Research Coordinator    +81668335012      
Principal Investigator: Takeshi Ogo, MD         
Fujita Health University Hospital Recruiting
Toyoake, Japan, 470-1192
Contact: Research Coordinator    81333531211      
Principal Investigator: Hidekata Yasuoka, MD         
Instituto Nacional de Cardiologia Dr. Ignacio Chavez Active, not recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 14080
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Active, not recruiting
Mexico City, Distrito Federal, Mexico, 14000
Hospital Civil Fray Antonio Alcalde Active, not recruiting
Guadalajara, Jalisco, Mexico, 44280
Hospital Universitario Dr. Jose Eleuterio González Active, not recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Unidad de Investigación Clínica En Medicina SC Active, not recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Vrije Universiteit Amsterdam Active, not recruiting
Amsterdam, Noord-Holland, Netherlands, 1007 MB
Angeles University Foundation Medical Center (AUFMC) Active, not recruiting
Angeles City, Philippines
Mary Mediatrix Medical Center (MMMC) Active, not recruiting
Lipa, Philippines
Makati Medical Center (MMC) Active, not recruiting
Makati, Philippines
Philippine General Hospital (PGH) Active, not recruiting
Manila, Philippines
Philippine Heart Center (PHC) Active, not recruiting
Quezon City, Philippines, 1100
Hospital Universitario Marques de Valdecilla Active, not recruiting
Santander, Cantabria, Spain
Hospital Universitario Vall d'Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital de Gran Canaria Doctor Negrin Active, not recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Universitario Puerta de Hierro Active, not recruiting
Majadahonda, Spain
Hospital Virgen de La Salud Active, not recruiting
Toledo, Spain, 45004
United Kingdom
Golden Jubilee National Hospital Active, not recruiting
Glasgow, United Kingdom, G81 4HX
Royal Free Hospital Active, not recruiting
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.

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Responsible Party: Reata Pharmaceuticals, Inc. Identifier: NCT02657356     History of Changes
Other Study ID Numbers: RTA 402-C-1504
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Reata Pharmaceuticals, Inc.:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Bardoxolone methyl
RTA 402
6-minute walk distance
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Connective Tissue Diseases
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases