A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
NCT ID: NCT00855465
Last Updated: 2023-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
262 participants
INTERVENTIONAL
2009-02-23
2012-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Riociguat (Adempas, BAY63-2521)_individual dose titration
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Placebo
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
Placebo
Matching Placebo tid orally for 16 weeks
Interventions
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Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Placebo
Matching Placebo tid orally for 16 weeks
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
Miami, Florida, 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
Innsbruck, , Austria
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
Qingdao, Shandong, China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Vseobecna fakultni nemocnice
Prague, , Czechia
Aarhus N, , Denmark
Brest, , France
Caen, , France
Hopital Antoine Beclere
Clamart, , France
Lille, , France
Nice, , France
Pessac, , France
Rouen, , France
Vandœuvre-lès-Nancy, , France
Heidelberg, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Würzburg, Bavaria, Germany
Giessen, Hesse, Germany
Hanover, Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Cologne, North Rhine-Westphalia, Germany
Homburg, Saarland, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Hamburg, , Germany
Pavia, Lombardy, Italy
Nagoya, Aichi-ken, Japan
Seto, Aichi-ken, Japan
Kitakyushu, Fukuoka, Japan
Komatsu, Ishikawa-ken, Japan
Fujisawa, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Sendai, Miyagi, Japan
Suwa, Nagano, Japan
Suita, Osaka, Japan
Bunkyo-ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Chiba, , Japan
Fukuoka, , Japan
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Mexico City, , Mexico
Querétaro, , Mexico
Amsterdam, , Netherlands
Krakow, , Poland
Otwock, , Poland
Coimbra, , Portugal
Novosibirsk, , Russia
Saint Petersburg, , Russia
Bratislava, , Slovakia
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Madrid, , Spain
Zurich, , Switzerland
Taipei, , Taiwan
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Cambridge, Cambridgeshire, United Kingdom
Glasgow, West Dunbartonshire, United Kingdom
London, , United Kingdom
Countries
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References
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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.
Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.
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.
Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.
Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.
Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. doi: 10.4143/crt.2015.278. Epub 2016 Feb 24.
Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. doi: 10.1007/s00535-016-1204-2. Epub 2016 Apr 22.
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.
Kim NH, D'Armini AM, Grimminger F, Grunig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.
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.
Other Identifiers
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2007-000072-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11348
Identifier Type: -
Identifier Source: org_study_id
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