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BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension (PATENT-2)

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ClinicalTrials.gov Identifier: NCT00863681
Recruitment Status : Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Extension, Multicentre, Multi-national 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 Symptomatic Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : March 12, 2009
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Arm 1 Drug: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid -2.5 mg tid oral until end of study



Primary Outcome Measures :
  1. Safety (adverse events collection) and tolerability [ Time Frame: Up to 4 years and 10 months ]

Secondary Outcome Measures :
  1. Change in 6MWD (6 minute walking distance) from baseline [ Time Frame: Up to 4 years and 10 months ]


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 12 weeks of treatment in the double blind trial PATENT 1

Exclusion Criteria:

  • Patients who have an ongoing serious adverse event from PATENT 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): NCT00863681


  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90073
Sacramento, California, United States, 95817
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02114
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43221
Fairfield, Ohio, United States, 45014
United States, Texas
Dallas, Texas, United States, 75390-9252
El Paso, Texas, United States, 79902
Argentina
Capital Federal, Argentina
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Chermside, Queensland, Australia, 4032
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Prahran, Victoria, Australia, 3181
Austria
Linz, Oberösterreich, Austria, 4020
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, 04012 180
São Paulo, Sao Paulo, Brazil, 04020-050
Rio de Janeiro, Brazil, 21941-913
Canada, Alberta
Calgary, Alberta, Canada, T1Y 6J4
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
China, Guangdong
Guangzhou, Guangdong, China, 510100
China
Beijing, China, 100020
Beijing, China, 100037
Shanghai, China, 200032
Shanghai, China, 200433
Czechia
Praha 2, Czechia, 12808
Denmark
Aarhus N, Denmark, 8200
France
Besancon, France, 25030
Brest, France, F-29609
GRENOBLE Cedex 09, France, 38043
Lille Cedex, France, 59037
Montpellier, France, 34059
Pessac, France, 33604
Rouen, France, 76031
Germany
Heidelberg, Baden-Württemberg, Germany, 69126
München, Bayern, Germany, 81377
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
Greece
Haidari, Greece, 124 62
Italy
Trieste, Friuli-Venezia Giulia, Italy, 34149
Roma, Lazio, Italy, 00161
Milano, Lombardia, Italy, 20123
Pavia, Lombardia, Italy, 27100
Japan
Nagoya, Aichi, Japan, 467-8602
Kobe, Hyogo, Japan, 650-0017
Toride, Ibaraki, Japan, 302-0022
Tsukuba, Ibaraki, Japan, 305-8576
Kanazawa, Ishikawa, Japan, 920-8641
Sendai, Miyagi, Japan, 980-8574
Tomigusuku, Okinawa, Japan, 901-0243
Bunkyo-ku, Tokyo, Japan, 113-8655
Mitaka, Tokyo, Japan, 181-8611
Ota-ku, Tokyo, Japan, 143-8541
Shinjuku-ku, Tokyo, Japan, 160-8582
Hiroshima, Japan, 734-8511
Okayama, Japan, 701-1192
Korea, Republic of
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Mexico
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 44280
Pulmocritic
Guadalajara, Jalisco, Mexico, 44670
Monterrey, Nuevo Leon, Mexico, 64020
Culiacan, Sinaloa, Mexico, 80020
Mexico D.F., Mexico, 14080
Querétaro, Mexico, 38000
Poland
Otwock, Poland, 05-400
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1169-024
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisboa, Portugal, 1649-035
Russian Federation
Moscow, Russian Federation, 121552
St. Petersburg, Russian Federation, 197341
Singapore
Singapore, Singapore, 119228
Singapore, Singapore, 168752
Sweden
Umeå, Sweden, 901 85
Switzerland
Zürich, Switzerland, 8091
Taiwan
Kaoshiung, Taiwan, 81346
Taipei, Taiwan, 10002
Taipei, Taiwan, 11217
Thailand
Bangkok, Thailand, 10330
Chiang Mai, Thailand, 50200
Turkey
Ankara, Turkey
Istanbul, Turkey, 34098
Izmir, Turkey, 35-100
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Clydebank, West Dunbartonshire, United Kingdom, G81 4DY
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00863681     History of Changes
Other Study ID Numbers: 12935
2008-003610-94 ( EudraCT Number )
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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

Keywords provided by Bayer:
Pulmonary arterial hypertension
PH
Stimulator

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