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Trial record 1 of 3 for:    Study of the Efficacy and Safety of Bardoxolone Methyl in Patients
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Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

This study is currently recruiting participants.
Verified December 2017 by Reata Pharmaceuticals, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02657356
First Posted: January 15, 2016
Last Update Posted: December 6, 2017
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.
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
  Purpose
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 Intervention Phase
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension Drug: Placebo capsules Drug: Bardoxolone methyl capsules Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Reata Pharmaceuticals, Inc.:

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

Estimated Enrollment: 200
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02657356


  Hide Study Locations
Locations
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         
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 Recruiting
Sacramento, California, United States, 95817
Contact: Research Coordinator    916-734-1554      
Principal Investigator: Roblee Allen, 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 Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Research Coordinator    352-273-8990      
Principal Investigator: Hassan Alnuaimat, MD         
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Research Coorindator    305-243-8567      
Principal Investigator: Eric Greidinger, 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 Recruiting
Chicago, Illinois, United States, 60611
Contact: Research Coordinator    312-695-2269      
Principal Investigator: Michael Cuttica, MD         
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Research Coordinator    312-355-5934      
Principal Investigator: Roberto Machado, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Research Coordinator    913-588-7117      
Principal Investigator: Lewis Satterwhite, MD         
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 Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Research Coordinator    318-675-5592      
Principal Investigator: Samina Hayat, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Research Coordinator    617-724-5548      
Principal Investigator: Richard Channick, MD         
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Research Coordinator    617-638-4475      
Principal Investigator: Harrison W. Farber, 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, New York
Beth Israel Medical Center 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         
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         
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 Recruiting
Norfolk, Virginia, United States, 23507
Contact: Research Coordinator    757-388-4024      
Principal Investigator: Michael Eggert, MD         
United States, Washington
Premier Clinical Research Withdrawn
Spokane, Washington, United States, 99202
United States, Wisconsin
Aurora Health Care Withdrawn
Milwaukee, Wisconsin, United States, 53215
Argentina
Fundación Favaloro Recruiting
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1093AAS
Contact: Research Coordinator    +5491158087041      
Principal Investigator: Jorge Caneva, MD         
Hospital Británico de Buenos Aires Recruiting
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1280AEB
Contact: Research Coordinator    +5491165491119      
Principal Investigator: Felipe Chertcoff, MD         
Centro Médico Dra de Salvo Recruiting
Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1426ABP
Contact: Research Coordinator    +541147815331      
Principal Investigator: Maria De Salvo, MD         
Instituto de Investigaciones Clínicas Mar Del Plata Recruiting
Buenos Aires, Mar Del Plata, Argentina, B7600FZN
Contact: Research Coordinator    +542234963224      
Principal Investigator: Alicia Rodriguez, MD         
Instituto De Enfermedades Respiratorias E Investigacion Medica Recruiting
Buenos Aires, Villa Vatteone, Argentina, B1853AIK
Contact: Research Coordinator    +541142555114      
Principal Investigator: Andrea Medina, MD         
Hospital Cordoba Recruiting
Cordoba, Argentina, X5004CDP
Contact: Research Coordinator    +03514860589      
Principal Investigator: Rodolfo Sarjanovich, MD         
Hospital Privado Centro Médico de Córdoba Recruiting
Cordoba, Argentina, X5016KEH
Contact: Research Coordinator    +5493513109070      
Principal Investigator: Oscar Salomone, MD         
Instituto de Cardiologia de Corrientes Juana Francisca Cabral Recruiting
Corrientes, Argentina, W3400AMZ
Contact: Research Coordinator    +543794410000      
Principal Investigator: Eduardo Perna, MD         
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Research Coordinator    +61295154188      
Principal Investigator: Peter Youssef, MD         
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Research Coordinator    +61283823265      
Principal Investigator: Anne Keogh, MD         
John Hunter Hospital Recruiting
New Lambton, New South Wales, Australia, 2305
Contact: Research Coordinator    +61249214095      
Principal Investigator: Glenn Reeves, MD         
Australia, Queensland
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Research Coordinator    +61731765145      
Principal Investigator: Sudhir Wahi, MD         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Research Coordinatro    +61361667881      
Principal Investigator: Nathan Dwyer, MD         
Belgium
UZ Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Research Coordinator    +3216346842      
Principal Investigator: Marion Delcroix, MD         
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Research Coordinator    +32025555602      
Principal Investigator: Jean-Luc Vachiery, MD         
Brazil
Hospital de Messejana Recruiting
Fortaleza, Ceara, Brazil, 60864-190
Contact: Research Coordinator    +558531017845      
Principal Investigator: Marcelo Rocha, MD         
Irmandade Da Santa Casa de Misericordia de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
Contact: Research Coordinator    +555132137068      
Principal Investigator: Gisela Meyer, MD         
Hospital Dia do Pulmão Recruiting
Blumenau, Santa Catarina, Brazil, 89010-000
Contact: Research Coordinator    +554730379527      
Principal Investigator: Marina Andrade Lima, MD         
Hospital São Paulo Recruiting
Sao Paulo, Brazil, 04023-900
Contact: Research Coordinator    +5511982739062      
Principal Investigator: Jaquelina Ota Arakaki, MD         
Instituto do Coração - HCFMUSP Recruiting
São Paulo, Brazil, 05403-900
Contact: Research Coordinator    +551126615109      
Principal Investigator: Rogerio de Souza, MD         
Canada, Alberta
Peter Lougheed Centre Recruiting
Calgary, Alberta, Canada, T1Y 6J4
Contact: Research Coordinator    403-943-4759      
Principal Investigator: Mitesh Thakrar, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Research Coordinator    780-407-3785      
Principal Investigator: Evangelos Michelakis, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Research Coordinator    604-875-4111 ext 69831      
Principal Investigator: John Swiston, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Research Coordinator    519-685-8500 ext 74817      
Principal Investigator: Sanjay Mehta, MD         
Canada, Quebec
Centre Hospitalier de l'Université Laval Recruiting
Sainte Foy, Quebec, Canada, G1V 4G5
Contact: Research Coordinator    418-656-8711 ext 2449      
Principal Investigator: Steeve Provencher, MD         
Chile
Centro de Investigación Clínica de la Universidad Católica Recruiting
Santiago, Región-MetropolitanadeSantiago, Chile, 8330024
Contact: Research Coordinator    +56223546438      
Principal Investigator: Pablo Castro Galvez, MD         
Hospital Las Higueras Withdrawn
Talcahuano, Chile, 4270918
Czechia
Vseobecna fakultni nemocnice v Praze Recruiting
Prague, Czechia, 128 00
Contact: Research Coordinator    +420224962365      
Principal Investigator: Pavel Jansa, MD         
Institut klinicke a experimentalni mediciny Recruiting
Prague, Czechia, 140 00
Contact: Research Coordinator    +420236053006      
Principal Investigator: Hikmet Al-Hiti, MD         
Germany
Universitätsklinikum Freiburg Recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Contact: Research Coordinator    +4976127037090      
Principal Investigator: Joachim Müller-Quernheim, MD         
Universitatsklinkum Erlangen Recruiting
Erlangen, Bayern, Germany, 91054
Contact: Research Coordinator    +4991318536925      
Principal Investigator: Jörg Distler, MD         
Universität Greifswald Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Contact: Research Coordinator    +4938348680073      
Principal Investigator: Ralf Ewert, MD         
DRK Kliniken Berlin Westend Recruiting
Berlin, Germany, 14050
Contact: Research Coordinator    +493030354305      
Principal Investigator: Christian Opitz, MD         
Universitätsklinikum Carl Gustav Carus an der TU Dresden Recruiting
Dresden, Germany, 01307
Contact: Research Coordinator    +493517965624      
Principal Investigator: Michael Halank, MD         
Universitätsklinikum Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Research Coordinator    +4940741057395      
Principal Investigator: Hans Klose, MD         
Thorax Klinik Recruiting
Heidelberg, Germany, 69126
Contact: Research Coordinator    +4962213968053      
Principal Investigator: Ekkehard Grünig, MD         
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Contact: Research Coordinator    +4922147832415      
Principal Investigator: Stephan Rosenkranz, MD         
Israel
Hadassah University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Research Coordinator    +97226777903      
Principal Investigator: Neville Berkman, MD         
Nazareth EMMS Hospital Recruiting
Nazareth, Israel, 16100
Contact: Research Coordinator    +972747559050      
Principal Investigator: William Nseir, MD         
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Contact: Research Coordinator    +97239377214      
Principal Investigator: Mordechai Kramer, MD         
ZIV Medical Center Recruiting
Safed, Israel, 13100
Contact: Research Coordinator    +97246828114      
Principal Investigator: Osama Hussein, MD         
Japan
Nippon Medical School Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8603
Contact: Research Coordinator    +81338222131      
Principal Investigator: Yuichiro Shirai, MD         
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: Research Coordinator    +0117161161      
Principal Investigator: Tatsuya Atsumi, MD         
Kitasato University Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0375
Contact: Research Coordinator    +427788111      
Principal Investigator: Sumiaki Tanaka, MD         
Kyorin University Hospital Recruiting
Tokyo, Mitaka-shi, Japan, 181-8611
Contact: Research Coordinator    +81422475511      
Principal Investigator: Toru Sato, 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         
Kobe University Hospital Recruiting
Kobe, Japan, 6500017
Contact: Research Coordinator    +81783825111      
Principal Investigator: Kazuhiko Nakayama, MD         
Nagoya City University Hospital Recruiting
Nagoya-shi, Japan, 467-8601
Contact: Research Coordinator    +81528587215      
Principal Investigator: Yutaka Takeda, 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         
Mexico
Instituto Nacional de Cardiologia Dr. Ignacio Chavez Recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 14080
Contact: Research Coordinator    +525555732911      
Principal Investigator: Tomas Pulido, MD         
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Distrito Federal, Mexico, 14000
Contact: Research Coordinator    +525558467831      
Principal Investigator: Tatiana Rodriquez-Reyna, MD         
Hospital Civil Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Research Coordinator    +523336149500      
Principal Investigator: Sergio Gutierrez-Urena, MD         
Hospital Universitario Dr. Jose Eleuterio González Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Research Coordinator    +528183482018      
Principal Investigator: Roberto Mercado Longoria, MD         
Unidad de Investigación Clínica En Medicina SC Recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Contact: Research Coordinator    +528181430795      
Principal Investigator: Alicia Ramirez, MD         
Netherlands
Vrije Universiteit Amsterdam Recruiting
Amsterdam, Noord-Holland, Netherlands, 1007 MB
Contact: Research Coordinator    +31204441634      
Principal Investigator: Anton Vonk Noordegraaf, MD         
Philippines
Angeles University Foundation Medical Center (AUFMC) Recruiting
Angeles City, Philippines
Contact: Research Coordinator    +639188233321      
Principal Investigator: Harold Michael Gomez, MD         
Mary Mediatrix Medical Center (MMMC) Recruiting
Lipa, Philippines
Contact: Research Coordinator    +639209099199      
Principal Investigator: Rhona Recto, MD         
Makati Medical Center (MMC) Recruiting
Makati, Philippines
Contact: Research Coordinator    +6915 350 9909      
Principal Investigator: Andrei Rhoneil Rodriguez, MD         
Philippine General Hospital (PGH) Not yet recruiting
Manila, Philippines
Contact: Research Coordinator    +639178993312      
Principal Investigator: Aileen D Wang, MD         
Philippine Heart Center (PHC) Recruiting
Quezon City, Philippines, 1100
Contact: Research Coordinator    +639175250616      
Principal Investigator: Teresita de Guia, MD         
Spain
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Cantabria, Spain
Contact: Research Coordinator    +34942202520      
Principal Investigator: Jose Manuel Cifrian Martinez, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Research Coordinator    +34932746107      
Principal Investigator: Cristina Berastegui, MD         
Hospital de Gran Canaria Doctor Negrin Recruiting
Las Palmas de Gran Canaria, Spain, 35010
Contact: Research Coordinator    +34928450563      
Principal Investigator: Gregorio Miguel Perez-Penate, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Research Coordinator    +34917792642      
Principal Investigator: Maria Pilar Escribano Subias, MD         
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Spain
Contact: Research Coordinator    +34911917297      
Principal Investigator: Javier Segovia Cubero, MD         
Hospital Virgen de La Salud Recruiting
Toledo, Spain, 45004
Contact: Research Coordinator    +34925269200      
Principal Investigator: Maria Lazaro Salvador, MD         
United Kingdom
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G81 4HX
Contact: Research Coordinator    +4401419515497      
Principal Investigator: Colin Church, MD         
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Research Coordinator    +4402073177544      
Principal Investigator: John Gerry Coghlan, MD         
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
  More Information

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02657356     History of Changes
Other Study ID Numbers: RTA 402-C-1504
First Submitted: January 13, 2016
First Posted: January 15, 2016
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Reata Pharmaceuticals, Inc.:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Bardoxolone methyl
PAH
RTA 402
6-minute walk distance

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Connective Tissue Diseases
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases