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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00910429
Recruitment Status : Active, not recruiting
First Posted : May 29, 2009
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):

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

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
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
La Jolla, California, United States, 92093
Sacramento, California, United States, 95817
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Gainesville, Florida, United States, 32610
Miami, Florida, United States, 33136
Weston, Florida, United States, 33331
United States, Georgia
Decatur, Georgia, United States, 30030
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02118
United States, New York
Rochester, New York, United States, 14642
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43221
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Providence, Rhode Island, United States, 02903
United States, Texas
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
United States, Utah
Murray, Utah, United States, 84107
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1039AAO
Capital Federal, Argentina
Corrientes, Argentina, 3400
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Chermside, Queensland, Australia, 4032
Australia, Victoria
Prahran, Victoria, Australia, 3181
Innsbruck, Austria, 6020
Wien, Austria, 1090
Bruxelles - Brussel, Belgium, 1070
Leuven, Belgium, 3000
Porto Alegre, Rio Grande Do Sul, Brazil, 90020 090
São Paulo, Sao Paulo, Brazil, 04020-050
Rio de Janeiro, Brazil, 21941-913
São Paulo, Brazil, 05403-000
Canada, Alberta
Calgary, Alberta, Canada, T1Y 6J4
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
London, Ontario, Canada, N6A 4G5
Ottawa, Ontario, Canada, K1Y 4W7
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
China, Shandong
Qingdao, Shandong, China
Beijing, China, 100020
Beijing, China, 100037
Beijing, China, 100038
Shanghai, China, 200433
Praha 2, Czechia, 12808
Aarhus N, Denmark, 8200
Copenhagen, Denmark, 2100
Besancon, France, 25030
Brest, France, F-29609
Caen, France, 14033
GRENOBLE Cedex 09, France, 38043
Le Kremlin Bicetre Cedex, France, 94275
Lille Cedex, France, 59037
Montpellier, France, 34059
Nice, France, 06200
Pessac, France, 33604
Rouen, France, 76031
Tours, France, 37000
Vandoeuvre Les Nancy, France, 54511
Heidelberg, Baden-Württemberg, Germany, 69120
Heidelberg, Baden-Württemberg, Germany, 69126
München, Bayern, Germany, 81377
Regensburg, Bayern, Germany, 93053
Würzburg, Bayern, Germany, 97074
Gießen, Hessen, Germany, 35392
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Hannover, Niedersachsen, Germany, 30625
Köln, Nordrhein-Westfalen, Germany, 50924
Homburg, Saarland, Germany, 66421
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04103
Hamburg, Germany, 20251
Dublin, Ireland, DUBLIN 7
Rabin Medical Center - Beilinson Campus
Petach Tikva, Israel
Ramat Gan, Israel, 5262000
Roma, Lazio, Italy, 00161
Pavia, Lombardia, Italy, 27100
Nagoya, Aichi, Japan, 467-8602
Seto, Aichi, Japan, 489-8642
Kitakyushu, Fukuoka, Japan, 802-8555
Komatsu, Ishikawa, Japan, 923-8560
Fujisawa, Kanagawa, Japan, 251-0041
Isehara, Kanagawa, Japan, 259-1193
Kawasaki, Kanagawa, Japan, 216-8511
Sendai, Miyagi, Japan, 980-8574
Suwa, Nagano, Japan, 392-8510
Suita, Osaka, Japan, 565-8565
Bunkyo-ku, Tokyo, Japan, 113-8655
Mitaka, Tokyo, Japan, 181-8611
Shinjuku-ku, Tokyo, Japan, 160-8582
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
Guadalajara, Jalisco, Mexico, 44670
Monterrey, Nuevo Leon, Mexico, 64460
Monterrey, Nuevo Leon, Mexico, 64718
Mexico D.F., Mexico, 14080
Querétaro, Mexico, 38000
Amsterdam, Netherlands, 1081 HV
Amsterdam, Netherlands, 1091 AC
Nieuwegein, Netherlands, 3435 CM
Krakow, Poland, 31-202
Otwock, Poland, 05-400
Wroclaw, Poland, 51-124
Coimbra, Portugal, 3000-075
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisboa, Portugal, 1649-035
Porto, Portugal, 4099-001
Russian Federation
Novosibirsk, Russian Federation, 630055
St. Petersburg, Russian Federation, 197341
Bratislava 37, Slovakia, 833 48
Barcelona, Spain, 08036
Madrid, Spain, 28041
Zürich, Switzerland, 8091
Kaohsiung, Taiwan, 833
Taipei, Taiwan, 10002
Ankara, Turkey
Istanbul, Turkey, 34-390
Izmir, Turkey, 35040
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
London, United Kingdom, W12 0HS
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
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: January 25, 2018
Last Verified: January 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
soluble Guanylate Cyclase Stimulator

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