check_circleStudy Completed

Pulmonary hypertension

Bayer Identifier:

12934

ClinicalTrials.gov Identifier:

NCT00810693

EudraCT Number:

2008-003482-68

EU CT Number:

Not Available
A study to evaluate efficacy and safety of oral BAY63-2521 in patients with Pulmonary Arterial Hypertension (PAH)

Trial purpose

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Key Participants Requirements

Sex

Both

Age

18 - 80 Years
  • - Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
    - Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
  • - All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.

Trial summary

Enrollment Goal
445
Trial Dates
December 2008 - May 2012
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
München, 81377, Germany
Completed
Homburg, 66421, Germany
Completed
Gießen, 35392, Germany
Completed
Leipzig, 04103, Germany
Completed
Greifswald, 17475, Germany
Withdrawn
Newcastle, NE7 7DN, United Kingdom
Completed
Cambridge, CB23 3RE, United Kingdom
Completed
London, NW3 2QG, United Kingdom
Completed
Clydebank, G81 4DY, United Kingdom
Completed
London, W12 0HS, United Kingdom
Completed
Aurora, 80045, United States
Completed
Sacramento, 95817, United States
Completed
Boston, 02115, United States
Completed
Columbus, 43221, United States
Completed
Dresden, 01307, Germany
Completed
Hannover, 30625, Germany
Completed
Köln, 50924, Germany
Completed
Heidelberg, 69126, Germany
Completed
Fairfield, 45014, United States
Withdrawn
Torrance, 90502, United States
Completed
Boston, 02111, United States
Withdrawn
Miami, 33136, United States
Withdrawn
Baltimore, 21205, United States
Withdrawn
Birmingham, 35233, United States
Completed
Lille Cedex, 59037, France
Withdrawn
Caen, 14033, France
Withdrawn
Asahikwa, 078-8510, Japan
Completed
Shinjuku-ku, 160-8582, Japan
Completed
Dallas, 75390, United States
Completed
Cleveland, 44195, United States
Withdrawn
Rochester, 55905, United States
Completed
Los Angeles, 90073, United States
Withdrawn
Pittsburgh, 15212, United States
Withdrawn
Atlanta, 30342, United States
Withdrawn
Portland, 04102, United States
Withdrawn
Clamart Cedex, 92141, France
Completed
Lille Cedex, 59037, France
Withdrawn
Lille Cedex, 59037, France
Withdrawn
Bron, 69500, France
Completed
BREST, F-29609, France
Completed
MONTPELLIER, 34059, France
Completed
GRENOBLE Cedex 09, 38043, France
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Nagoya, 467-8602, Japan
Completed
Kanazawa, 920-8641, Japan
Completed
Tomigusuku, 901-0243, Japan
Completed
Kobe, 650-0017, Japan
Withdrawn
Tokushima, 770-8503, Japan
Completed
Tsukuba, 305-8576, Japan
Completed
Milano, 20123, Italy
Completed
Trieste, 34149, Italy
Completed
Torino, 10043, Italy
Withdrawn
Madrid, 28041, Spain
Withdrawn
Quebec, G1V 4G5, Canada
Completed
LEUVEN, 3000, Belgium
Completed
Monterrey, 64020, Mexico
Completed
Culiacan, 80020, Mexico
Completed
Lund, 221 85, Sweden
Withdrawn
Marseille, 13385, France
Completed
Otwock, 05-400, Poland
Withdrawn
Krakow, 31-202, Poland
Completed
Sendai, 980-8574, Japan
Completed
Ota-ku, 143-8541, Japan
Completed
Sagamihara, 252-0375, Japan
Withdrawn
Toyoake, 470-1192, Japan
Completed
Okayama, 701-1192, Japan
Completed
Hiroshima, 734-8551, Japan
Withdrawn
Hamamatsu, 430-0929, Japan
Withdrawn
Fukuoka, 812-8582, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Toride, 302-0022, Japan
Withdrawn
Bologna, 40138, Italy
Completed
Pavia, 27100, Italy
Completed
Umeå, 901 85, Sweden
Completed
Praha 2, 12808, Czechia
Completed
DARLINGHURST, 2010, Australia
Completed
Herston, 4029, Australia
Completed
Royal Hobart HospitalHOBART, 7000, Australia
Withdrawn
Heidelberg, 3084, Australia
Completed
Porto, 4099-001, Portugal
Withdrawn
Buenos Aires, C1093AAS, Argentina
Withdrawn
Buenos Aires, C1120AAF, Argentina
Withdrawn
Vicente López, 1638, Argentina
Completed
Wien, 1090, Austria
Completed
Innsbruck, 6020, Austria
Completed
Porto Alegre, 90020 090, Brazil
Withdrawn
São Paulo, 05403-000, Brazil
Completed
Roma, 00161, Italy
Completed
Barcelona, 08036, Spain
Completed
Barcelona, 08035, Spain
Completed
Sevilla, 41013, Spain
Completed
Toronto, M5G 2N2, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
Calgary, T1Y 6J4, Canada
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Withdrawn
Amsterdam, 1081 HV, Netherlands
Completed
Mexico D.F., 14080, Mexico
Completed
Linköping, 581 85, Sweden
Completed
Aarhus N, 8200, Denmark
Withdrawn
Jerusalem, 9112001, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Rio de Janeiro, 21941-913, Brazil
Completed
St. Petersburg, 197341, Russian Federation
Completed
Beijing, 100020, China
Completed
Seoul, 05505, Korea, Republic Of
Completed
Zürich, 8091, Switzerland
Completed
Taipei, 100, Taiwan
Completed
Kaohsiung City, 813414, Taiwan
Completed
Christchurch, 8011, New Zealand
Completed
Petah Tikva, 4941492, Israel
Withdrawn
Tel Aviv, 6423906, Israel
Completed
Auchenflower, 4066, Australia
Completed
PRAHRAN, 3181, Australia
Completed
New Lambton Heights, 2305, Australia
Completed
Coimbra, 3000-075, Portugal
Withdrawn
Almada, 2801-951, Portugal
Withdrawn
Buenos Aires, C1039AAO, Argentina
Completed
Linz, 4020, Austria
Completed
Ankara, Turkey
Completed
Izmir, 35-100, Turkey
Completed
Istanbul, 34098, Turkey
Completed
Chaidari, 124 62, Greece
Withdrawn
Kallithea / Athens, 17674, Greece
Completed
São Paulo, 04020-050, Brazil
Completed
São Paulo, 04012 180, Brazil
Completed
Moscow, 121552, Russian Federation
Completed
Beijing, 100037, China
Completed
Shanghai, 200433, China
Completed
Shanghai, 200032, China
Completed
Guangzhou, 510100, China
Completed
Seoul, 06351, Korea, Republic Of
Completed
Taipei, 11217, Taiwan
Withdrawn
Taichung, 40705, Taiwan
Completed
Singapore, 168752, Singapore
Completed
Singapore, 119228, Singapore
Withdrawn
Dublin, Ireland
Completed
Houston, 77030, United States
Withdrawn
Newark, 07103, United States
Withdrawn
ROTTERDAM, 3015 CE, Netherlands
Completed
Providence, 02903, United States
Completed
Rouen, 76031, France
Withdrawn
Tours, 37000, France
Withdrawn
Gainesville, 32610, United States
Completed
Cincinnati, 45219, United States
Completed
Yoshida, 910-1193, Japan
Withdrawn
St. Louis, 63110, United States
Withdrawn
Iowa City, 52242, United States
Withdrawn
Sheffield, S10 2JF, United Kingdom
Withdrawn
Baltimore, 21201, United States
Completed
Seoul, 03722, Korea, Republic Of
Withdrawn
Boston, 02114, United States
Completed
El Paso, 79902, United States
Completed
Capital Federal, Argentina
Completed
Seoul, 03080, Korea, Republic Of
Completed
Omaha, 68131, United States
Completed
La Jolla, 92037, United States
Completed
New York, 10032, United States
Withdrawn
Ann Arbor, 48109, United States
Withdrawn
Weston, 33331, United States
Completed
Louisville, 40202, United States
Completed
Tuscon, 85724, United States
Completed
Guadalajara, 44670, Mexico
Completed
Guadalajara, 44280, Mexico
Completed
Querétaro, 38000, Mexico
Withdrawn
Buenos Aires, C1199ABB, Argentina
Withdrawn
Cleveland, 44106, United States
Withdrawn
Istanbul, 34304, Turkey
Completed
Chiang Mai, 50200, Thailand
Withdrawn
Bangkok, 10400, Thailand
Completed
Lisboa, 1169-024, Portugal
Completed
Lisboa, 1649-035, Portugal
Completed
PESSAC, 33604, France
Withdrawn
Hamilton, L8L 2X2, Canada
Completed
Bangkok, 10330, Thailand
Completed
NICE, 06200, France
Withdrawn
Sarasota, 34239, United States
Completed
BESANCON, 25030, France
Withdrawn
Fresno, 93721, United States
Withdrawn
Rochester, 14642, United States

Primary Outcome

  • 6 minutes walking distance (6MWD) - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Pulmonary vascular resistance (PVR) - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • N-terminal prohormone of brain natriuretic peptide (NT-proBNP) - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • World Health Organization (WHO) functional class - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with clinical worsening
    date_rangeTime Frame:
    At week 12
    enhanced_encryption
    Safety Issue:
    No
  • Borg CR 10 scale - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • EQ-5D utility score - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No
  • Living with pulmonary hypertension (LPH) questionnaire - Change from baseline to week 12
    date_rangeTime Frame:
    Baseline and week 12
    enhanced_encryption
    Safety Issue:
    No

Trial design

Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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