check_circleStudy Completed

Pulmonary Hypertension

Bayer Identifier:

11349

ClinicalTrials.gov Identifier:

NCT00910429

EudraCT Number:

2008-003539-19

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

Both

Age

18 - 80 Years

  • - Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

  • - Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial

Trial summary

Enrollment Goal
237
Trial Dates
July 2009 - August 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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Withdrawn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 CampusPetach 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 MariaLisboa, 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 death
    Analyses 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 Coagulation
    Frequency 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 coagulation
    Frequency 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 coagulation
    Hemoglobin 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 chemistry
    Frequency 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 chemistry
    Frequency 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 chemistry
    Urate 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

Long-term extension, multicentre, multi-international study to evaluate the safety and tolerability of oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg tid) in patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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