check_circleStudy Completed
Pulmonary hypertension
Bayer Identifier:
12934
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to evaluate efficacy and safety of oral BAY63-2521 in patients with Pulmonary Arterial Hypertension (PAH)
Trial purpose
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
Key Participants Requirements
Sex
BothAge
18 - 80 YearsTrial summary
Enrollment Goal
445Trial Dates
December 2008 - May 2012Phase
Phase 3Could I Receive a placebo
YesProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | München, 81377, Germany | |
Completed | Homburg, 66421, Germany | |
Completed | Gießen, 35392, Germany | |
Completed | Leipzig, 04103, Germany | |
Completed | Greifswald, 17475, Germany | |
Withdrawn | Newcastle, NE7 7DN, United Kingdom | |
Completed | Cambridge, CB23 3RE, United Kingdom | |
Completed | London, NW3 2QG, United Kingdom | |
Completed | Clydebank, G81 4DY, United Kingdom | |
Completed | London, W12 0HS, United Kingdom | |
Completed | Aurora, 80045, United States | |
Completed | Sacramento, 95817, United States | |
Completed | Boston, 02115, United States | |
Completed | Columbus, 43221, United States | |
Completed | Dresden, 01307, Germany | |
Completed | Hannover, 30625, Germany | |
Completed | Köln, 50924, Germany | |
Completed | Heidelberg, 69126, Germany | |
Completed | Fairfield, 45014, United States | |
Withdrawn | Torrance, 90502, United States | |
Completed | Boston, 02111, United States | |
Withdrawn | Miami, 33136, United States | |
Withdrawn | Baltimore, 21205, United States | |
Withdrawn | Birmingham, 35233, United States | |
Completed | Lille Cedex, 59037, France | |
Withdrawn | Caen, 14033, France | |
Withdrawn | Asahikwa, 078-8510, Japan | |
Completed | Shinjuku-ku, 160-8582, Japan | |
Completed | Dallas, 75390, United States | |
Completed | Cleveland, 44195, United States | |
Withdrawn | Rochester, 55905, United States | |
Completed | Los Angeles, 90073, United States | |
Withdrawn | Pittsburgh, 15212, United States | |
Withdrawn | Atlanta, 30342, United States | |
Withdrawn | Portland, 04102, United States | |
Withdrawn | Clamart Cedex, 92141, France | |
Completed | Lille Cedex, 59037, France | |
Withdrawn | Lille Cedex, 59037, France | |
Withdrawn | Bron, 69500, France | |
Completed | BREST, F-29609, France | |
Completed | MONTPELLIER, 34059, France | |
Completed | GRENOBLE Cedex 09, 38043, France | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Nagoya, 467-8602, Japan | |
Completed | Kanazawa, 920-8641, Japan | |
Completed | Tomigusuku, 901-0243, Japan | |
Completed | Kobe, 650-0017, Japan | |
Withdrawn | Tokushima, 770-8503, Japan | |
Completed | Tsukuba, 305-8576, Japan | |
Completed | Milano, 20123, Italy | |
Completed | Trieste, 34149, Italy | |
Completed | Torino, 10043, Italy | |
Withdrawn | Madrid, 28041, Spain | |
Withdrawn | Quebec, G1V 4G5, Canada | |
Completed | LEUVEN, 3000, Belgium | |
Completed | Monterrey, 64020, Mexico | |
Completed | Culiacan, 80020, Mexico | |
Completed | Lund, 221 85, Sweden | |
Withdrawn | Marseille, 13385, France | |
Completed | Otwock, 05-400, Poland | |
Withdrawn | Krakow, 31-202, Poland | |
Completed | Sendai, 980-8574, Japan | |
Completed | Ota-ku, 143-8541, Japan | |
Completed | Sagamihara, 252-0375, Japan | |
Withdrawn | Toyoake, 470-1192, Japan | |
Completed | Okayama, 701-1192, Japan | |
Completed | Hiroshima, 734-8551, Japan | |
Withdrawn | Hamamatsu, 430-0929, Japan | |
Withdrawn | Fukuoka, 812-8582, Japan | |
Completed | Mitaka, 181-8611, Japan | |
Completed | Toride, 302-0022, Japan | |
Withdrawn | Bologna, 40138, Italy | |
Completed | Pavia, 27100, Italy | |
Completed | Umeå, 901 85, Sweden | |
Completed | Praha 2, 12808, Czechia | |
Completed | DARLINGHURST, 2010, Australia | |
Completed | Herston, 4029, Australia | |
Completed | Royal Hobart Hospital | HOBART, 7000, Australia |
Withdrawn | Heidelberg, 3084, Australia | |
Completed | Porto, 4099-001, Portugal | |
Withdrawn | Buenos Aires, C1093AAS, Argentina | |
Withdrawn | Buenos Aires, C1120AAF, Argentina | |
Withdrawn | Vicente López, 1638, Argentina | |
Completed | Wien, 1090, Austria | |
Completed | Innsbruck, 6020, Austria | |
Completed | Porto Alegre, 90020 090, Brazil | |
Withdrawn | São Paulo, 05403-000, Brazil | |
Completed | Roma, 00161, Italy | |
Completed | Barcelona, 08036, Spain | |
Completed | Barcelona, 08035, Spain | |
Completed | Sevilla, 41013, Spain | |
Completed | Toronto, M5G 2N2, Canada | |
Completed | Montreal, H3T 1E2, Canada | |
Completed | Calgary, T1Y 6J4, Canada | |
Completed | BRUXELLES - BRUSSEL, 1070, Belgium | |
Withdrawn | Amsterdam, 1081 HV, Netherlands | |
Completed | Mexico D.F., 14080, Mexico | |
Completed | Linköping, 581 85, Sweden | |
Completed | Aarhus N, 8200, Denmark | |
Withdrawn | Jerusalem, 9112001, Israel | |
Completed | Petah Tikva, 4941492, Israel | |
Completed | Rio de Janeiro, 21941-913, Brazil | |
Completed | St. Petersburg, 197341, Russian Federation | |
Completed | Beijing, 100020, China | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Zürich, 8091, Switzerland | |
Completed | Taipei, 100, Taiwan | |
Completed | Kaohsiung City, 813414, Taiwan | |
Completed | Christchurch, 8011, New Zealand | |
Completed | Petah Tikva, 4941492, Israel | |
Withdrawn | Tel Aviv, 6423906, Israel | |
Completed | Auchenflower, 4066, Australia | |
Completed | PRAHRAN, 3181, Australia | |
Completed | New Lambton Heights, 2305, Australia | |
Completed | Coimbra, 3000-075, Portugal | |
Withdrawn | Almada, 2801-951, Portugal | |
Withdrawn | Buenos Aires, C1039AAO, Argentina | |
Completed | Linz, 4020, Austria | |
Completed | Ankara, Turkey | |
Completed | Izmir, 35-100, Turkey | |
Completed | Istanbul, 34098, Turkey | |
Completed | Chaidari, 124 62, Greece | |
Withdrawn | Kallithea / Athens, 17674, Greece | |
Completed | São Paulo, 04020-050, Brazil | |
Completed | São Paulo, 04012 180, Brazil | |
Completed | Moscow, 121552, Russian Federation | |
Completed | Beijing, 100037, China | |
Completed | Shanghai, 200433, China | |
Completed | Shanghai, 200032, China | |
Completed | Guangzhou, 510100, China | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Taipei, 11217, Taiwan | |
Withdrawn | Taichung, 40705, Taiwan | |
Completed | Singapore, 168752, Singapore | |
Completed | Singapore, 119228, Singapore | |
Withdrawn | Dublin, Ireland | |
Completed | Houston, 77030, United States | |
Withdrawn | Newark, 07103, United States | |
Withdrawn | ROTTERDAM, 3015 CE, Netherlands | |
Completed | Providence, 02903, United States | |
Completed | Rouen, 76031, France | |
Withdrawn | Tours, 37000, France | |
Withdrawn | Gainesville, 32610, United States | |
Completed | Cincinnati, 45219, United States | |
Completed | Yoshida, 910-1193, Japan | |
Withdrawn | St. Louis, 63110, United States | |
Withdrawn | Iowa City, 52242, United States | |
Withdrawn | Sheffield, S10 2JF, United Kingdom | |
Withdrawn | Baltimore, 21201, United States | |
Completed | Seoul, 03722, Korea, Republic Of | |
Withdrawn | Boston, 02114, United States | |
Completed | El Paso, 79902, United States | |
Completed | Capital Federal, Argentina | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Omaha, 68131, United States | |
Completed | La Jolla, 92037, United States | |
Completed | New York, 10032, United States | |
Withdrawn | Ann Arbor, 48109, United States | |
Withdrawn | Weston, 33331, United States | |
Completed | Louisville, 40202, United States | |
Completed | Tuscon, 85724, United States | |
Completed | Guadalajara, 44670, Mexico | |
Completed | Guadalajara, 44280, Mexico | |
Completed | Querétaro, 38000, Mexico | |
Withdrawn | Buenos Aires, C1199ABB, Argentina | |
Withdrawn | Cleveland, 44106, United States | |
Withdrawn | Istanbul, 34304, Turkey | |
Completed | Chiang Mai, 50200, Thailand | |
Withdrawn | Bangkok, 10400, Thailand | |
Completed | Lisboa, 1169-024, Portugal | |
Completed | Lisboa, 1649-035, Portugal | |
Completed | PESSAC, 33604, France | |
Withdrawn | Hamilton, L8L 2X2, Canada | |
Completed | Bangkok, 10330, Thailand | |
Completed | NICE, 06200, France | |
Withdrawn | Sarasota, 34239, United States | |
Completed | BESANCON, 25030, France | |
Withdrawn | Fresno, 93721, United States | |
Withdrawn | Rochester, 14642, United States |
Primary Outcome
- 6 minutes walking distance (6MWD) - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Pulmonary vascular resistance (PVR) - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP) - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
- World Health Organization (WHO) functional class - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
- Percentage of participants with clinical worseningdate_rangeTime Frame:At week 12enhanced_encryptionNoSafety Issue:
- Borg CR 10 scale - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
- EQ-5D utility score - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
- Living with pulmonary hypertension (LPH) questionnaire - Change from baseline to week 12date_rangeTime Frame:Baseline and week 12enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3