check_circleStudy Completed
Pulmonary Hypertension
Bayer Identifier:
11349
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY63-2521 - Long-term extension study in patients with chronic thromboembolic pulmonary hypertension
Trial purpose
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
Key Participants Requirements
Sex
BothAge
18 - 80 YearsTrial summary
Enrollment Goal
237Trial Dates
July 2009 - August 2019Phase
Phase 3Could I Receive a placebo
NoProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hannover, 30625, Germany | |
Completed | München, 81377, Germany | |
Completed | Dresden, 01307, Germany | |
Completed | Leipzig, 04103, Germany | |
Completed | Hamburg, 20251, Germany | |
Completed | Cambridge, CB23 3RE, United Kingdom | |
Withdrawn | Newcastle, NE7 7DN, United Kingdom | |
Completed | Sacramento, 95817, United States | |
Withdrawn | Boston, 02115, United States | |
Completed | Columbus, 43221, United States | |
Withdrawn | Miami, 33136, United States | |
Completed | Dallas, 75390, United States | |
Completed | Cleveland, 44195, United States | |
Completed | Gießen, 35392, Germany | |
Completed | Homburg, 66421, Germany | |
Completed | Köln, 50924, Germany | |
Withdrawn | Greifswald, 17475, Germany | |
Completed | Heidelberg, 69126, Germany | |
Withdrawn | Heidelberg, 69120, Germany | |
Completed | Glasgow, G81 4DY, United Kingdom | |
Withdrawn | Fairfield, 45014, United States | |
Withdrawn | Aurora, 80045, United States | |
Completed | Baltimore, 21205, United States | |
Withdrawn | Decatur, 30030, United States | |
Completed | BREST, F-29609, France | |
Withdrawn | Lille Cedex, 59037, France | |
Completed | La Jolla, 92093, United States | |
Withdrawn | Pittsburgh, 15212, United States | |
Withdrawn | Birmingham, 35233, United States | |
Completed | LE KREMLIN BICETRE CEDEX, 94275, France | |
Completed | VANDOEUVRE LES NANCY, 54511, France | |
Withdrawn | Suita, 565-8565, Japan | |
Withdrawn | Mitaka, 181-8611, Japan | |
Completed | Fujisawa, 251-0041, Japan | |
Completed | Suwa, 392-8510, Japan | |
Completed | Pavia, 27100, Italy | |
Completed | Calgary, T1Y 6J4, Canada | |
Withdrawn | NIEUWEGEIN, 3435 CM, Netherlands | |
Completed | Monterrey, 64718, Mexico | |
Withdrawn | Monterrey, 64460, Mexico | |
Withdrawn | MONTPELLIER, 34059, France | |
Withdrawn | Caen, 14033, France | |
Withdrawn | Wroclaw, 51-124, Poland | |
Completed | Otwock, 05-400, Poland | |
Completed | Krakow, 31-202, Poland | |
Completed | Sendai, 980-8574, Japan | |
Completed | Chiba, 260-8677, Japan | |
Withdrawn | Shinjuku-ku, 160-8582, Japan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Nagoya, 467-8602, Japan | |
Completed | Fukuoka, 812-8582, Japan | |
Withdrawn | Roma, 00161, Italy | |
Withdrawn | Madrid, 28041, Spain | |
Completed | Barcelona, 08036, Spain | |
Completed | Toronto, M5G 2N2, Canada | |
Completed | Montreal, H3T 1E2, Canada | |
Completed | LEUVEN, 3000, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1070, Belgium | |
Withdrawn | Amsterdam, 1081 HV, Netherlands | |
Completed | Aarhus N, 8200, Denmark | |
Completed | Praha 2, 12808, Czechia | |
Withdrawn | Ramat Gan, 5262000, Israel | |
Withdrawn | Camperdown, 2050, Australia | |
Withdrawn | Porto, 4099-001, Portugal | |
Withdrawn | Buenos Aires, C1039AAO, Argentina | |
Completed | Istanbul, 34093, Turkey | |
Withdrawn | São Paulo, 05403-000, Brazil | |
Completed | Rio de Janeiro, 21941-913, Brazil | |
Completed | Bratislava 37, 833 48, Slovakia | |
Withdrawn | Qingdao, China | |
Completed | Seoul, 138-736, Korea, Republic Of | |
Completed | Zürich, 8091, Switzerland | |
Withdrawn | Kaohsiung, 833, Taiwan | |
Completed | Querétaro, 38000, Mexico | |
Withdrawn | Copenhagen, 2100, Denmark | |
Terminated | Rabin Medical Center - Beilinson Campus | Petach Tikva, Israel |
Withdrawn | Herston, 4029, Australia | |
Withdrawn | Auchenflower, 4066, Australia | |
Completed | PRAHRAN, 3181, Australia | |
Completed | Coimbra, 3000-075, Portugal | |
Completed | Wien, 1090, Austria | |
Withdrawn | Innsbruck, 6020, Austria | |
Completed | Ankara, Turkey | |
Completed | Izmir, 35040, Turkey | |
Completed | São Paulo, 04020-050, Brazil | |
Completed | Porto Alegre, 90020 090, Brazil | |
Completed | St. Petersburg, 197341, Russian Federation | |
Completed | Beijing, 100037, China | |
Completed | Beijing, 100020, China | |
Completed | Shanghai, 200433, China | |
Withdrawn | Beijing, 100038, China | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Taipei, 100, Taiwan | |
Withdrawn | Dublin, D07 R2WY, Ireland | |
Withdrawn | Houston, 77030, United States | |
Withdrawn | GRENOBLE Cedex 09, 38043, France | |
Completed | Shinjuku-ku, 162-8655, Japan | |
Withdrawn | Seto, 489-8642, Japan | |
Completed | London, N6A 4G5, Canada | |
Completed | Novosibirsk, 630055, Russian Federation | |
Withdrawn | Providence, 02903, United States | |
Withdrawn | Gainesville, 32610, United States | |
Completed | Rouen, 76031, France | |
Withdrawn | Tours, 37000, France | |
Withdrawn | Baltimore, 21201, United States | |
Withdrawn | Boston, 02114, United States | |
Withdrawn | Murray, 84107, United States | |
Completed | Boston, 02118, United States | |
Withdrawn | Capital Federal, Argentina | |
Completed | Iowa City, 52242, United States | |
Completed | Würzburg, 97074, Germany | |
Withdrawn | Weston, 33331, United States | |
Completed | Kitakyushu, 802-8555, Japan | |
Withdrawn | Isehara, 259-1193, Japan | |
Completed | Mexico D.F., 14080, Mexico | |
Withdrawn | Guadalajara, 44670, Mexico | |
Withdrawn | Regensburg, 93053, Germany | |
Withdrawn | AMSTERDAM, 1091 AC, Netherlands | |
Terminated | Centro Hospitalar de Lisboa Norte - Hospital Santa Maria | Lisboa, 1649-035, Portugal |
Completed | Komatsu, 923-8560, Japan | |
Completed | Corrientes, 3400, Argentina | |
Withdrawn | London, W12 0HS, United Kingdom | |
Completed | Ottawa, K1Y 4W7, Canada | |
Withdrawn | Hamilton, L8L 2X2, Canada | |
Completed | Kawasaki, 216-8511, Japan | |
Withdrawn | Pessac, 33604, France | |
Withdrawn | NICE, 06200, France | |
Withdrawn | BESANCON, 25030, France | |
Withdrawn | Rochester, 14642, United States |
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAE)Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.date_rangeTime Frame:From administration of first dose of study medication up to 2 days after end of treatment with study medication.
- Number of participants with deathAnalyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.date_rangeTime Frame:From baseline to end of safety follow-up visit
Secondary Outcome
- Percentage of participants with treatment-emergent high laboratory abnormalities in Hematology and CoagulationFrequency of participants with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.date_rangeTime Frame:From baseline to Termination visit, up to 10 years
- Percentage of participants with treatment-emergent low laboratory abnormalities in Hematology and coagulationFrequency of participants with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.date_rangeTime Frame:From baseline to Termination visit, up to 10 years
- Change from baseline of hemoglobin in Hematology and coagulationHemoglobin is standard Hematology and coagulation parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.date_rangeTime Frame:From baseline to Termination visit, up to 10 years
- Percentage of participants with treatment-emergent high laboratory abnormalities in Clinical chemistryFrequency of participants per treatment group with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.date_rangeTime Frame:From baseline to Termination visit, up to 10 years
- Percentage of participants with treatment-emergent low laboratory abnormalities in Clinical chemistryFrequency of participants per treatment group with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.date_rangeTime Frame:From baseline to Termination visit, up to 10 years
- Change from baseline of urate in Clinical chemistryUrate is standard clinical chemistry parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.date_rangeTime Frame:From baseline to Termination visit, up to 10 years
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1