A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT00810693
Last Updated: 2023-11-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
445 participants
INTERVENTIONAL
2008-12-17
2012-05-14
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) up to 2.5 mg_IDT
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 12 weeks
Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT
Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Placebo
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
Placebo
Matching Placebo tid orally for 12 weeks
Interventions
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Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Placebo
Matching Placebo tid orally for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
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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Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Fairfield, Ohio, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Capital Federal, , Argentina
Darlinghurst, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Auchenflower, Queensland, Australia
Herston, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Prahran, Victoria, Australia
Linz, Upper Austria, Austria
Innsbruck, , Austria
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Guangzhou, Guangdong, China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Prague, , Czechia
Aarhus N, , Denmark
Besançon, , France
Brest, , France
Grenoble, , France
Lille, , France
Montpellier, , France
Nice, , France
Pessac, , France
Rouen, , France
Heidelberg, Baden-Wurttemberg, Germany
München, 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
Chaïdári, , Greece
Petah Tikva, , Israel
Trieste, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Turin, Piedmont, Italy
Nagoya, Aichi-ken, Japan
Yoshida, Fukui, Japan
Kobe, Hyōgo, Japan
Toride, Ibaraki, Japan
Tsukuba, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Sagamihara, Kanagawa, Japan
Sendai, Miyagi, Japan
Tomigusuku, Okinawa, Japan
Bunkyo-ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Hiroshima, , Japan
Okayama, , Japan
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Culiacán, Sinaloa, Mexico
Mexico City, , Mexico
Querétaro, , Mexico
Christchurch, , New Zealand
Otwock, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Moscow, , Russia
Saint Petersburg, , Russia
Singapore, , Singapore
Singapore, , Singapore
Seoul, Seoul Teugbyeolsi, South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Barcelona, , Spain
Seville, , Spain
Linköping, , Sweden
Lund, , Sweden
Umeå, , Sweden
Zurich, , Switzerland
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Cambridge, Cambridgeshire, United Kingdom
Clydebank, West Dunbartonshire, United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
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References
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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.
Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.
Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.
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.
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.
Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.
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.
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Other Identifiers
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2008-003482-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12934
Identifier Type: -
Identifier Source: org_study_id