Trial Condition(s):
Pulmonary hypertension
BAY63-2521 - Long-term extension study in patients with chronic thromboembolic pulmonary hypertension (CHEST-2)
Bayer Identifier:
11349
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Hamburg, Germany, 20251 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Columbus, United States, 43221 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Dallas, United States, 75390 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Glasgow, United Kingdom, G81 4DY | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Baltimore, United States, 21205 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site BREST, France, F-29609 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site La Jolla, United States, 92093 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site LE KREMLIN BICETRE CEDEX, France, 94275 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site VANDOEUVRE LES NANCY, France, 54511 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Fujisawa, Japan, 251-0041 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Suwa, Japan, 392-8510 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Calgary, Canada, T1Y 6J4 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Monterrey, Mexico, 64718 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Otwock, Poland, 05-400 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Krakow, Poland, 31-202 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Rio de Janeiro, Brazil, 21941-913 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bratislava 37, Slovakia, 833 48 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Querétaro, Mexico, 38000 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site PRAHRAN, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Ankara, Turkey | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Izmir, Turkey, 35040 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site São Paulo, Brazil, 04020-050 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Porto Alegre, Brazil, 90020 090 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site St. Petersburg, Russia, 197341 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Beijing, China, 100037 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Beijing, China, 100020 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Shanghai, China, 200433 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Seoul, South Korea, 06351 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Shinjuku-ku, Japan, 162-8655 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site London, Canada, N6A 4G5 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Novosibirsk, Russia, 630055 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Rouen, France, 76031 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Würzburg, Germany, 97074 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Mexico D.F., Mexico, 14080 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Komatsu, Japan, 923-8560 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Corrientes, Argentina, 3400 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Ottawa, Canada, K1Y 4W7 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kawasaki, Japan, 216-8511 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
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
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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: From baseline to Termination visit, up to 10 years
Additional Information
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