check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

12935

ClinicalTrials.gov Identifier:

NCT00863681

EudraCT Number:

2008-003610-94

EU CT Number:

Not Available
BAY63-2521:Long-term extension study in patients with pulmonary arterial hypertension

Trial purpose

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years
  • - Patients who have completed 12 weeks of
    treatment in the double blind trial PATENT 1
  • - Patients who have an ongoing serious adverse event from PATENT 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial.

Trial summary

Enrollment Goal
396
Trial Dates
March 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
Homburg, 66421, Germany
Completed
Gießen, 35392, Germany
Completed
Leipzig, 04103, Germany
Completed
Köln, 50924, Germany
Withdrawn
Newcastle, NE7 7DN, United Kingdom
Completed
Fairfield, 45014, United States
Completed
Sacramento, 95817, United States
Completed
Dallas, 75390-9252, United States
Withdrawn
Rochester, 55905, United States
Withdrawn
Birmingham, 35233, United States
Withdrawn
Portland, 04102, United States
Withdrawn
Clamart Cedex, 92141, France
Withdrawn
LILLE, 59037, France
Completed
München, 81377, Germany
Completed
Dresden, 01307, Germany
Completed
Hannover, 30625, Germany
Completed
Heidelberg, 69126, Germany
Completed
Greifswald, 17475, Germany
Completed
Cambridge, CB23 3RE, United Kingdom
Completed
London, NW3 2QG, United Kingdom
Completed
Clydebank, G81 4DY, United Kingdom
Withdrawn
London, W12 0HS, United Kingdom
Completed
Aurora, 80045, United States
Withdrawn
Torrance, 90502, United States
Completed
Boston, 02111, United States
Withdrawn
Miami, 33136, United States
Withdrawn
Lille Cedex, 59037, France
Completed
Lille Cedex, 59037, France
Withdrawn
Caen, 14033, France
Withdrawn
Marseille, 13385, France
Completed
Bunkyo-ku, 113-8655, Japan
Withdrawn
Sagamihara, 252-0375, Japan
Completed
Nagoya, 467-8602, Japan
Withdrawn
Toyoake, 470-1192, Japan
Completed
Kanazawa, 920-8641, Japan
Completed
Hiroshima, 734-8551, Japan
Withdrawn
Tokushima, 770-8503, Japan
Withdrawn
Fukuoka, 812-8582, Japan
Completed
Tsukuba, 305-8576, Japan
Completed
Toride, 302-0022, Japan
Completed
Trieste, 34149, Italy
Completed
Boston, 02114, United States
Completed
Columbus, 43221, United States
Completed
Cleveland, 44195, United States
Completed
Los Angeles, 90073, United States
Withdrawn
Baltimore, 21205, United States
Withdrawn
Pittsburgh, 15212, United States
Withdrawn
Bron, 69500, France
Completed
BREST, F-29609, France
Completed
MONTPELLIER, 34059, France
Completed
GRENOBLE Cedex 09, 38043, France
Completed
Otwock, 05-400, Poland
Withdrawn
Krakow, 31-202, Poland
Withdrawn
Asahikwa, 078-8510, Japan
Completed
Sendai, 980-8574, Japan
Withdrawn
Torino, 10043, Italy
Withdrawn
Madrid, 28041, Spain
Withdrawn
Toronto, M5G 2N2, Canada
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
LEUVEN, 3000, Belgium
Withdrawn
Amsterdam, 1081 HV, Netherlands
Completed
Mexico D.F., 14080, Mexico
Completed
Culiacan, 80020, Mexico
Completed
Umeå, 901 85, Sweden
Withdrawn
Linköping, 581 85, Sweden
Completed
Aarhus N, 8200, Denmark
Completed
Praha 2, 12808, Czechia
Withdrawn
Jerusalem, 9112001, Israel
Withdrawn
Petah Tikva, 4941492, Israel
Withdrawn
Petah Tikva, 4941492, Israel
Completed
Shinjuku-ku, 160-8582, Japan
Completed
Ota-ku, 143-8541, Japan
Completed
Okayama, 701-1192, Japan
Completed
Tomigusuku, 901-0243, Japan
Withdrawn
Hamamatsu, 430-0929, Japan
Completed
Kobe, 650-0017, Japan
Completed
Mitaka, 181-8611, Japan
Withdrawn
Bologna, 40138, Italy
Completed
Pavia, 27100, Italy
Completed
Roma, 00161, Italy
Completed
Milano, 20123, Italy
Withdrawn
Barcelona, 08036, Spain
Withdrawn
Barcelona, 08035, Spain
Withdrawn
Sevilla, 41013, Spain
Withdrawn
Quebec, G1V 4G5, Canada
Completed
DARLINGHURST, 2010, Australia
Completed
Herston, 4029, Australia
Completed
PRAHRAN, 3181, Australia
Withdrawn
New Lambton Heights, 2305, Australia
Completed
HOBART, 7000, Australia
Withdrawn
Heidelberg, 3084, Australia
Completed
Coimbra, 3000-075, Portugal
Withdrawn
Buenos Aires, C1093AAS, Argentina
Withdrawn
Buenos Aires, C1120AAF, Argentina
Withdrawn
Vicente López, 1638, Argentina
Withdrawn
Kallithea / Athens, 17674, Greece
Withdrawn
São Paulo, 05403-000, Brazil
Completed
São Paulo, 04012 180, Brazil
Completed
Montreal, H3T 1E2, Canada
Completed
Calgary, T1Y 6J4, Canada
Completed
Monterrey, 64020, Mexico
Withdrawn
Lund, 221 85, Sweden
Withdrawn
Tel Aviv, 6423906, Israel
Completed
Auchenflower, 4066, Australia
Withdrawn
Porto, 4099-001, Portugal
Withdrawn
Almada, 2801-951, Portugal
Withdrawn
Buenos Aires, C1039AAO, Argentina
Completed
Wien, 1090, Austria
Completed
Innsbruck, 6020, Austria
Completed
Linz, 4020, Austria
Completed
Ankara, Turkey
Completed
Izmir, 35-100, Turkey
Completed
Istanbul, 34098, Turkey
Completed
Rio de Janeiro, 21941-913, Brazil
Completed
Shanghai, 200433, China
Completed
Shanghai, 200032, China
Completed
Seoul, 06351, Korea, Republic Of
Completed
Zürich, 8091, Switzerland
Completed
Taipei, 100, Taiwan
Withdrawn
Taichung, 40705, Taiwan
Completed
Singapore, 119228, Singapore
Completed
Chaidari, 124 62, Greece
Completed
Porto Alegre, 90020 090, Brazil
Completed
São Paulo, 04020-050, Brazil
Completed
Moscow, 121552, Russian Federation
Completed
St. Petersburg, 197341, Russian Federation
Completed
Beijing, 100037, China
Completed
Guangzhou, 510100, China
Completed
Beijing, 100020, China
Completed
Seoul, 05505, Korea, Republic Of
Completed
Taipei, 11217, Taiwan
Completed
Kaohsiung City, 813414, Taiwan
Completed
Singapore, 168752, Singapore
Withdrawn
Christchurch, 8011, New Zealand
Withdrawn
Dublin, Ireland
Withdrawn
Houston, 77030, United States
Withdrawn
Newark, 07103, United States
Withdrawn
STRASBOURG, 67098, France
Withdrawn
Praha 4, 140 21, Czechia
Withdrawn
Providence, 02903, United States
Withdrawn
Gainesville, 32610, United States
Withdrawn
Cincinnati, 45219, United States
Withdrawn
Yoshida, 910-1193, Japan
Withdrawn
St. Louis, 63110, United States
Withdrawn
Iowa City, 52242, United States
Completed
Rouen, 76031, France
Withdrawn
Tours, 37000, France
Withdrawn
Baltimore, 21201, United States
Withdrawn
Boston, 02114, United States
Completed
El Paso, 79902, United States
Completed
Capital Federal, Argentina
Completed
Seoul, 03722, Korea, Republic Of
Withdrawn
Seoul, 03080, Korea, Republic Of
Completed
Omaha, 68131, United States
Withdrawn
La Jolla, 92037, United States
Withdrawn
New York, 10032, United States
Withdrawn
Ann Arbor, 48109, United States
Withdrawn
ROTTERDAM, 3015 CE, Netherlands
Withdrawn
Weston, 33331, United States
Withdrawn
Louisville, 40202, United States
Withdrawn
Tucson, 85724, United States
Terminated
PulmocriticGuadalajara, 44670, Mexico
Terminated
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, 44280, Mexico
Completed
Querétaro, 38000, Mexico
Withdrawn
Cleveland, 44106, United States
Withdrawn
Istanbul, 34304, Turkey
Completed
Chiang Mai, 50200, Thailand
Withdrawn
Bangkok, 10400, Thailand
Completed
Lisboa, 1169-024, Portugal
Completed
Centro Hospitalar de Lisboa Norte - Hospital Santa MariaLisboa, 1649-035, Portugal
Withdrawn
Buenos Aires, C1199ABB, Argentina
Withdrawn
Sheffield, S10 2JF, United Kingdom
Withdrawn
Hamilton, L8L 2X2, Canada
Completed
Bangkok, 10330, Thailand
Completed
Pessac, 33604, France
Withdrawn
NICE, 06200, France
Withdrawn
Sarasota, 34239, United States
Completed
BESANCON, 25030, France
Withdrawn
Fresno, 93721, United States
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 in PATENT-2 up to 2 days after end of treatment with study medication.
  • Number of participant 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
    Percentage 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. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after 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
    Percentage 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. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after 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 high laboratory abnormalities in Clinical chemistry
    Percentage 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. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after 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
    Percentage 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. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after 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

Trial design

Long-term extension, multicentre, multi-national 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 symptomatic pulmonary arterial hypertension (PAH)
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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