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:

NCT00910429

EudraCT Number:

2008-003539-19

Study Completed

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
237
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20251

Status
Completed
 
Locations

Investigative Site

Cambridge, United Kingdom, CB23 3RE

Status
Completed
 
Locations

Investigative Site

Sacramento, United States, 95817

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43221

Status
Completed
 
Locations

Investigative Site

Dallas, United States, 75390

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

Homburg, Germany, 66421

Status
Completed
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
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Investigative Site

Heidelberg, Germany, 69126

Status
Completed
 
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Investigative Site

Glasgow, United Kingdom, G81 4DY

Status
Completed
 
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Investigative Site

Baltimore, United States, 21205

Status
Completed
 
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Investigative Site

BREST, France, F-29609

Status
Completed
 
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Investigative Site

La Jolla, United States, 92093

Status
Completed
 
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Investigative Site

LE KREMLIN BICETRE CEDEX, France, 94275

Status
Completed
 
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Investigative Site

VANDOEUVRE LES NANCY, France, 54511

Status
Completed
 
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Investigative Site

Fujisawa, Japan, 251-0041

Status
Completed
 
Locations

Investigative Site

Suwa, Japan, 392-8510

Status
Completed
 
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Investigative Site

Pavia, Italy, 27100

Status
Completed
 
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Investigative Site

Calgary, Canada, T1Y 6J4

Status
Completed
 
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Investigative Site

Monterrey, Mexico, 64718

Status
Completed
 
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Investigative Site

Otwock, Poland, 05-400

Status
Completed
 
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Investigative Site

Krakow, Poland, 31-202

Status
Completed
 
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Investigative Site

Sendai, Japan, 980-8574

Status
Completed
 
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Investigative Site

Chiba, Japan, 260-8677

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
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Investigative Site

Nagoya, Japan, 467-8602

Status
Completed
 
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Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

Toronto, Canada, M5G 2N2

Status
Completed
 
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Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Investigative Site

Istanbul, Turkey, 34093

Status
Completed
 
Locations

Investigative Site

Rio de Janeiro, Brazil, 21941-913

Status
Completed
 
Locations

Investigative Site

Bratislava 37, Slovakia, 833 48

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Querétaro, Mexico, 38000

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel

Status
Terminated
 
Locations

Investigative Site

PRAHRAN, Australia, 3181

Status
Completed
 
Locations

Investigative Site

Coimbra, Portugal, 3000-075

Status
Completed
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Ankara, Turkey

Status
Completed
 
Locations

Investigative Site

Izmir, Turkey, 35040

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 04020-050

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90020 090

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197341

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100037

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200433

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 06351

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 10016

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

London, Canada, N6A 4G5

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630055

Status
Completed
 
Locations

Investigative Site

Rouen, France, 76031

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Iowa City, United States, 52242

Status
Completed
 
Locations

Investigative Site

Würzburg, Germany, 97074

Status
Completed
 
Locations

Investigative Site

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Investigative Site

Mexico D.F., Mexico, 14080

Status
Completed
 
Locations

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisboa, Portugal, 1649-035

Status
Terminated
 
Locations

Investigative Site

Komatsu, Japan, 923-8560

Status
Completed
 
Locations

Investigative Site

Corrientes, Argentina, 3400

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1Y 4W7

Status
Completed
 
Locations

Investigative Site

Kawasaki, Japan, 216-8511

Status
Completed
 

Trial Design