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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00910429
First received: May 27, 2009
Last updated: August 25, 2014
Last verified: August 2014
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ] [ Designated as safety issue: No ]

Enrollment: 237
Study Start Date: July 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910429

  Hide Study Locations
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, 21205
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02114
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
Argentina
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
Austria
Innsbruck, Austria, 6020
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, 04024-002
Rio de Janeiro, Brazil, 21941-900
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
China
Beijing, China, 100037
Beijing, China, 100020
Beijing, China, 100038
Shanghai, China, 200433
Czech Republic
Praha 2, Czech Republic, 12800
Denmark
Aarhus N, Denmark, 8200
Copenhagen, Denmark, 2100
France
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
Germany
Heidelberg, Baden-Württemberg, Germany, 69126
Heidelberg, Baden-Württemberg, Germany, 69120
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
Ireland
Dublin, Ireland, DUBLIN 7
Israel
Petach Tikva, Israel
Tel Hashomer, Israel, 5262000
Italy
Pavia, Italy, 27100
Roma, Italy, 00161
Japan
Nagoya, Aichi, Japan, 467-8602
Seto, Aichi, Japan, 489-8642
Kitakyushu, Fukuoka, Japan, 802-8555
Komatsu, Ishikawa, Japan, 923-0961
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, 162-8655
Shinjuku-ku, Tokyo, Japan, 160-8582
Chiba, Japan, 260-8677
Fukuoka, Japan, 812-8582
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Mexico
Guadalajara, Jalisco, Mexico, 44670
Monterrey, Nuevo Leon, Mexico, 64460
Monterrey, Nuevo Leon, Mexico, 64718
Mexico D.F., Mexico, 14080
Querétaro, Mexico, 38000
Netherlands
Amsterdam, Netherlands, 1091 AC
Amsterdam, Netherlands, 1081 HV
Nieuwegein, Netherlands, 3435 CM
Poland
Krakow, Poland, 31-202
Otwock, Poland, 05-400
Wroclaw, Poland, 51-124
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1649-035
Porto, Portugal, 4099-001
Russian Federation
Novosibirsk, Russian Federation, 630055
St. Petersburg, Russian Federation, 197341
Slovakia
Bratislava 37, Slovakia, 833 48
Spain
Barcelona, Spain, 08036
Madrid, Spain, 28041
Switzerland
Zürich, Switzerland, 8091
Taiwan
Kaohsiung, Taiwan, 833
Taipei, Taiwan, 10016
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
London, United Kingdom, W12 0HS
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional 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
Study First Received: May 27, 2009
Last Updated: August 25, 2014
Health Authority: Argentina: National Administration of Drugs, Foods and Medical Technology
Australia: Department of Health
Austria: Ministry of Labor, Health and Social Affairs
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Protection Branch
China: Ministry of Health- State Food and Drug Administration
Czech Republic: Ministry of Health
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health and Welfare
Korea, Republic of:Korea: Food and Drug Administration
Mexico: Ministry of Health
Netherlands: Medicines Evaluetion Board
Poland: Ministry of Health and Social Security- Drug Institute
Portugal: Ministry of Health
Russia: Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Ministry of Health and Consumption
Switzerland: Federal Office of Public Health
Taiwan: Department of Health
Turkey: Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014