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:

NCT00855465

EudraCT Number:

2007-000072-16

EU CT Number:

Not Available

Study Completed

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
262
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Gießen, Germany, 35392

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München, Germany, 81377

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Homburg, Germany, 66421

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Köln, Germany, 50924

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Greifswald, Germany, 17475

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Hamburg, Germany, 20251

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Columbus, United States, 43221

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Cleveland, United States, 44195

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Baltimore, United States, 21205

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La Jolla, United States, 92093

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Hannover, Germany, 30625

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Dresden, Germany, 01307

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Leipzig, Germany, 04103

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Heidelberg, Germany, 69126

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Heidelberg, Germany, 69120

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Cambridge, United Kingdom, CB23 3RE

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Glasgow, United Kingdom, G81 4DY

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Sacramento, United States, 95817

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Miami, United States, 33136

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Dallas, United States, 75390

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BREST, France, F-29609

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VANDOEUVRE LES NANCY, France, F-54500

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Lille Cedex, France, 59037

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Shinjuku-ku, Japan, 160-8582

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Nagoya, Japan, 467-8602

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Suita, Japan, 565-8565

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Fukuoka, Japan, 812-8582

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Mitaka, Japan, 181-8611

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Fujisawa, Japan, 251-0041

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Suwa, Japan, 392-8510

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Toronto, Canada, M5G 2N2

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LEUVEN, Belgium, 3000

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BRUXELLES - BRUSSEL, Belgium, 1070

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Hopital Antoine Beclere

Clamart Cedex, France, 92141

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Caen, France, 14033

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Otwock, Poland, 05-400

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Krakow, Poland, 31-202

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Sendai, Japan, 980-8574

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Chiba, Japan, 260-8677

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Bunkyo-ku, Japan, 113-8655

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Pavia, Italy, 27100

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Madrid, Spain, 28041

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Barcelona, Spain, 08036

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Montreal, Canada, H3T 1E2

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Amsterdam, Netherlands, 1081 HV

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Aarhus N, Denmark, 8200

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Vseobecna fakultni nemocnice

Praha 2, Czech Republic, 12808

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PRAHRAN, Australia, 3181

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Innsbruck, Austria, 6020

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Istanbul, Turkey, 34093

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São Paulo, Brazil, 04020-050

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Rio de Janeiro, Brazil, 21941-913

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St. Petersburg, Russia, 197341

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Beijing, China, 100037

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Qingdao, China, 266003

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Calgary, Canada, T1Y 6J4

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Monterrey, Mexico, 64020

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Monterrey, Mexico, 64460

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Querétaro, Mexico, 38000

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Coimbra, Portugal, 3000-075

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Wien, Austria, 1090

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Ankara, Turkey

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Izmir, Turkey, 35040

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Porto Alegre, Brazil, 90020 090

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Bratislava 37, Slovakia, 833 48

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Shanghai, China, 200433

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Beijing, China, 100038

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Seoul, South Korea, 138-736

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Beijing, China, 100020

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Seoul, South Korea, 06351

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Zürich, Switzerland, 8091

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Taipei, Taiwan, China, 100

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Shinjuku-ku, Japan, 162-8655

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Seto, Japan, 489-8642

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London, Canada, N6A 4G5

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Novosibirsk, Russia, 630055

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Rouen, France, 76031

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Boston, United States, 02118

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Iowa City, United States, 52242

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Würzburg, Germany, 97074

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Kitakyushu, Japan, 802-8555

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Mexico D.F., Mexico, 14080

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London, United Kingdom, W12 0HS

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Ottawa, Canada, K1Y 4W7

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Komatsu, Japan, 923-8560

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Corrientes, Argentina, 3400

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PESSAC, France, 33604

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Kawasaki, Japan, 216-8511

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NICE, France, 06200

Trial Design