Trial Condition(s):
Pulmonary hypertension
A study to evaluate efficacy and safety of oral BAY63-2521 in patients with CTEPH. (CHEST-1)
Bayer Identifier:
11348
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Inclusion Criteria
- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.
Exclusion Criteria
- All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20251 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glasgow, United Kingdom, G81 4DY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75390 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BREST, France, F-29609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VANDOEUVRE LES NANCY, France, F-54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lille Cedex, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-8565 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fujisawa, Japan, 251-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suwa, Japan, 392-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Antoine Beclere Clamart Cedex, France, 92141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Caen, France, 14033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Otwock, Poland, 05-400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amsterdam, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vseobecna fakultni nemocnice Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PRAHRAN, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 04020-050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rio de Janeiro, Brazil, 21941-913 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197341 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Qingdao, China, 266003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T1Y 6J4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey, Mexico, 64020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey, Mexico, 64460 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Querétaro, Mexico, 38000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ankara, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90020 090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava 37, Slovakia, 833 48 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200433 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 06351 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seto, Japan, 489-8642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novosibirsk, Russia, 630055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rouen, France, 76031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mexico D.F., Mexico, 14080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, W12 0HS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1Y 4W7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Komatsu, Japan, 923-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corrientes, Argentina, 3400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PESSAC, France, 33604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawasaki, Japan, 216-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 6 minutes walking distance (6MWD) - Change from baseline to week 16Timeframe: Baseline and week 16
Secondary Outcome
- Pulmonary vascular resistance (PVR) - Change from baseline to week 16Timeframe: Baseline and week 16
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP) - Change from baseline to week 16Timeframe: Baseline and week 16
- World Health Organization (WHO) functional class - Change from baseline to week 16Timeframe: Baseline and week 16
- Percentage of particpants with clinical worseningTimeframe: At week 16
- Borg CR 10 scale - Change from baseline to week 16Timeframe: Baseline and week 16
- EQ-5D utility score - Change from baseline to week 16Timeframe: Baseline and week 16
- Living with pulmonary hypertension (LPH) questionnaire - Change from baseline to week 16Timeframe: Baseline and week 16
Additional Information
Not Available
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