BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
NCT ID: NCT00910429
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
237 participants
INTERVENTIONAL
2009-07-01
2019-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Interventions
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Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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La Jolla, California, United States
Sacramento, California, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dallas, Texas, United States
Corrientes, , Argentina
Prahran, Victoria, Australia
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Calgary, Alberta, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Beijing, , China
Beijing, , China
Shanghai, , China
Prague, , Czechia
Aarhus N, , Denmark
Brest, , France
Le Kremlin-Bicêtre, , France
Rouen, , France
Vandœuvre-lès-Nancy, , France
Heidelberg, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Würzburg, Bavaria, Germany
Giessen, Hesse, Germany
Hanover, Lower Saxony, Germany
Cologne, North Rhine-Westphalia, Germany
Homburg, Saarland, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Hamburg, , Germany
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Pavia, Lombardy, Italy
Nagoya, Aichi-ken, Japan
Kitakyushu, Fukuoka, Japan
Komatsu, Ishikawa-ken, Japan
Fujisawa, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Sendai, Miyagi, Japan
Suwa, Nagano, Japan
Bunkyo-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Chiba, , Japan
Fukuoka, , Japan
Monterrey, Nuevo León, Mexico
Mexico City, , Mexico
Querétaro, , Mexico
Krakow, , Poland
Otwock, , Poland
Coimbra, , Portugal
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisbon, , Portugal
Novosibirsk, , Russia
Saint Petersburg, , Russia
Bratislava, , Slovakia
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Zurich, , Switzerland
Taipei, , Taiwan
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Cambridge, Cambridgeshire, United Kingdom
Glasgow, West Dunbartonshire, United Kingdom
Countries
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References
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Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.
Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.
Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.
Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.
Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.
Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Click here to find results for studies related to Bayer products
Other Identifiers
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2008-003539-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11349
Identifier Type: -
Identifier Source: org_study_id
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