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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

Investigative Site

Homburg, Germany, 66421

Status
Completed
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
Locations

Investigative Site

Greifswald, Germany, 17475

Status
Completed
 
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Investigative Site

Hamburg, Germany, 20251

Status
Completed
 
Locations

Investigative Site

Newcastle, United Kingdom, NE7 7DN

Status
Terminated
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Terminated
 
Locations

Investigative Site

Columbus, United States, 43221

Status
Completed
 
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Cleveland, United States, 44195

Status
Completed
 
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Investigative Site

Baltimore, United States, 21205

Status
Completed
 
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Investigative Site

La Jolla, United States, 92093

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15212

Status
Terminated
 
Locations

Investigative Site

Atlanta, United States, 30342

Status
Terminated
 
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Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Dresden, Germany, 01307

Status
Completed
 
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Leipzig, Germany, 04103

Status
Completed
 
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Investigative Site

Heidelberg, Germany, 69126

Status
Completed
 
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Heidelberg, Germany, 69120

Status
Completed
 
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Investigative Site

Cambridge, United Kingdom, CB23 3RE

Status
Completed
 
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Investigative Site

Glasgow, United Kingdom, G81 4DY

Status
Completed
 
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Fairfield, United States, 45014

Status
Terminated
 
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Investigative Site

Sacramento, United States, 95817

Status
Completed
 
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Investigative Site

Boston, United States, 02115

Status
Terminated
 
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Investigative Site

Miami, United States, 33136

Status
Completed
 
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Dallas, United States, 75390

Status
Completed
 
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Decatur, United States, 30030

Status
Terminated
 
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Birmingham, United States, 35233

Status
Terminated
 
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Investigative Site

BREST, France, F-29609

Status
Completed
 
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Investigative Site

VANDOEUVRE LES NANCY, France, F-54500

Status
Completed
 
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Investigative Site

Lille Cedex, France, 59037

Status
Completed
 
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Investigative Site

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

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Nagoya, Japan, 467-8602

Status
Completed
 
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Suita, Japan, 565-8565

Status
Completed
 
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Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
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Mitaka, Japan, 181-8611

Status
Completed
 
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Investigative Site

Fujisawa, Japan, 251-0041

Status
Completed
 
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Suwa, Japan, 392-8510

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 2N2

Status
Completed
 
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Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
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Investigative Site

NIEUWEGEIN, Netherlands, 3435 CM

Status
Terminated
 
Locations

Hopital Antoine Beclere

Clamart Cedex, France, 92141

Status
Completed
 
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Investigative Site

MONTPELLIER, France, 34059

Status
Terminated
 
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Investigative Site

Caen, France, 14033

Status
Completed
 
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Investigative Site

GRENOBLE Cedex 09, France, 38043

Status
Terminated
 
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Wroclaw, Poland, 51-124

Status
Terminated
 
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Otwock, Poland, 05-400

Status
Completed
 
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Krakow, Poland, 31-202

Status
Completed
 
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Sendai, Japan, 980-8574

Status
Completed
 
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Chiba, Japan, 260-8677

Status
Completed
 
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Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
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Investigative Site

Pavia, Italy, 27100

Status
Completed
 
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Investigative Site

Roma, Italy, 00161

Status
Terminated
 
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Investigative Site

Madrid, Spain, 28041

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
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Investigative Site

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
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Investigative Site

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Vseobecna fakultni nemocnice

Praha 2, Czech Republic, 12808

Status
Completed
 
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Investigative Site

Petah Tikva, Israel, 4941492

Status
Terminated
 
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Investigative Site

PRAHRAN, Australia, 3181

Status
Completed
 
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Investigative Site

Buenos Aires, Argentina, C1039AAO

Status
Terminated
 
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Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
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Investigative Site

Istanbul, Turkey, 34-390

Status
Completed
 
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Investigative Site

São Paulo, Brazil, 05403-000

Status
Terminated
 
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Investigative Site

São Paulo, Brazil, 04024-002

Status
Completed
 
Locations

Investigative Site

Rio de Janeiro, Brazil, 21941-900

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197341

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100037

Status
Completed
 
Locations

Investigative Site

Qingdao, China, 266003

Status
Completed
 
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Investigative Site

Calgary, Canada, T1Y 6J4

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64020

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64460

Status
Completed
 
Locations

Investigative Site

Querétaro, Mexico, 38000

Status
Completed
 
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Investigative Site

Camperdown, Australia, 2050

Status
Terminated
 
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Investigative Site

Chermside, Australia, 4032

Status
Terminated
 
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Investigative Site

Auchenflower, Australia, 4066

Status
Terminated
 
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Investigative Site

Coimbra, Portugal, 3000-075

Status
Completed
 
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Investigative Site

Porto, Portugal, 4099-001

Status
Terminated
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Ankara, Turkey

Status
Completed
 
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Investigative Site

Izmir, Turkey, 35040

Status
Completed
 
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Investigative Site

Porto Alegre, Brazil, 90020 090

Status
Completed
 
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Investigative Site

Bratislava 37, Slovakia, 833 48

Status
Completed
 
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Investigative Site

Shanghai, China, 200433

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100038

Status
Completed
 
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Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Investigative Site

Kaohsiung, Taiwan, China, 833

Status
Terminated
 
Locations

Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
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Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 10016

Status
Completed
 
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Investigative Site

Dublin, Ireland, DUBLIN 7

Status
Terminated
 
Locations

Investigative Site

Houston, United States, 77030

Status
Terminated
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

Seto, Japan, 489-8642

Status
Completed
 
Locations

Investigative Site

London, Canada, N6A 4G5

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630055

Status
Completed
 
Locations

Investigative Site

Providence, United States, 02903

Status
Terminated
 
Locations

Investigative Site

Rouen, France, 76031

Status
Completed
 
Locations

Investigative Site

Tours, France, 37000

Status
Terminated
 
Locations

Investigative Site

Gainesville, United States, 32610

Status
Terminated
 
Locations

Investigative Site

Baltimore, United States, 21201

Status
Terminated
 
Locations

Investigative Site

Boston, United States, 02114

Status
Terminated
 
Locations

Investigative Site

Murray, United States, 84107

Status
Terminated
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Capital Federal, Argentina

Status
Terminated
 
Locations

Investigative Site

Iowa City, United States, 52242

Status
Completed
 
Locations

Investigative Site

Würzburg, Germany, 97074

Status
Completed
 
Locations

Investigative Site

Milwaukee, United States, 53215

Status
Terminated
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Terminated
 
Locations

Investigative Site

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Investigative Site

Weston, United States, 33331

Status
Terminated
 
Locations

Investigative Site

Isehara, Japan, 259-1193

Status
Terminated
 
Locations

Investigative Site

Mexico D.F., Mexico, 14080

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, 44670

Status
Terminated
 
Locations

Investigative Site

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Investigative Site

Regensburg, Germany, 93053

Status
Terminated
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1091 AC

Status
Terminated
 
Locations

Investigative Site

Lisboa, Portugal, 1649-035

Status
Terminated
 
Locations

Investigative Site

Ottawa, Canada, K1Y 4W7

Status
Completed
 
Locations

Investigative Site

Komatsu, Japan, 923-8560

Status
Completed
 
Locations

Investigative Site

Corrientes, Argentina, 3400

Status
Completed
 
Locations

Investigative Site

PESSAC, France, 33604

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8L 2X2

Status
Terminated
 
Locations

Investigative Site

Kawasaki, Japan, 216-8511

Status
Completed
 
Locations

Investigative Site

NICE, France, 06200

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SW3 6NP

Status
Terminated
 
Locations

Investigative Site

BESANCON, France, 25030

Status
Terminated
 
Locations

Investigative Site

Rochester, United States, 14642

Status
Terminated
 

Trial Design