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BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2)

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ClinicalTrials.gov Identifier: NCT00910429
Recruitment Status : Active, not recruiting
First Posted : May 29, 2009
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Riociguat (Adempas, BAY63-2521) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : July 1, 2009
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Arm 1 Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study



Primary Outcome Measures :
  1. Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ]

Secondary Outcome Measures :
  1. Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910429


  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92093
Sacramento, California, United States, 95817
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43221
United States, Texas
Dallas, Texas, United States, 75390
Argentina
Corrientes, Argentina, 3400
Australia, Victoria
Prahran, Victoria, Australia, 3181
Austria
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1070
Leuven, Belgium, 3000
Brazil
Porto Alegre, Rio Grande Do Sul, Brazil, 90020 090
São Paulo, Sao Paulo, Brazil, 04020-050
Rio de Janeiro, Brazil, 21941-913
Canada, Alberta
Calgary, Alberta, Canada, T1Y 6J4
Canada, Ontario
London, Ontario, Canada, N6A 4G5
Ottawa, Ontario, Canada, K1Y 4W7
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
China
Beijing, China, 100020
Beijing, China, 100037
Shanghai, China, 200433
Czechia
Praha 2, Czechia, 12808
Denmark
Aarhus N, Denmark, 8200
France
Brest, France, F-29609
Le Kremlin Bicetre Cedex, France, 94275
Rouen, France, 76031
Vandoeuvre Les Nancy, France, 54511
Germany
Heidelberg, Baden-Württemberg, Germany, 69126
München, Bayern, Germany, 81377
Würzburg, Bayern, Germany, 97074
Gießen, Hessen, Germany, 35392
Hannover, Niedersachsen, Germany, 30625
Köln, Nordrhein-Westfalen, Germany, 50924
Homburg, Saarland, Germany, 66421
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04103
Hamburg, Germany, 20251
Israel
Rabin Medical Center - Beilinson Campus
Petach Tikva, Israel
Italy
Pavia, Lombardia, Italy, 27100
Japan
Nagoya, Aichi, Japan, 467-8602
Kitakyushu, Fukuoka, Japan, 802-8555
Komatsu, Ishikawa, Japan, 923-8560
Fujisawa, Kanagawa, Japan, 251-0041
Kawasaki, Kanagawa, Japan, 216-8511
Sendai, Miyagi, Japan, 980-8574
Suwa, Nagano, Japan, 392-8510
Bunkyo-ku, Tokyo, Japan, 113-8655
Shinjuku-ku, Tokyo, Japan, 162-8655
Chiba, Japan, 260-8677
Fukuoka, Japan, 812-8582
Korea, Republic of
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Mexico
Monterrey, Nuevo Leon, Mexico, 64718
Mexico D.F., Mexico, 14080
Querétaro, Mexico, 38000
Poland
Krakow, Poland, 31-202
Otwock, Poland, 05-400
Portugal
Coimbra, Portugal, 3000-075
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisboa, Portugal, 1649-035
Russian Federation
Novosibirsk, Russian Federation, 630055
St. Petersburg, Russian Federation, 197341
Slovakia
Bratislava 37, Slovakia, 833 48
Spain
Barcelona, Spain, 08036
Switzerland
Zürich, Switzerland, 8091
Taiwan
Taipei, Taiwan, 10002
Turkey
Ankara, Turkey
Istanbul, Turkey, 34-390
Izmir, Turkey, 35040
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00910429     History of Changes
Other Study ID Numbers: 11349
2008-003539-19 ( EudraCT Number )
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Chronic thromboembolic Hypertension
PH
soluble Guanylate Cyclase Stimulator
sGC

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases