check_circleStudy Completed

Pulmonary hypertension

Bayer Identifier:

11348

ClinicalTrials.gov Identifier:

NCT00855465

EudraCT Number:

2007-000072-16

EU CT Number:

Not Available
A study to evaluate efficacy and safety of oral BAY63-2521 in patients with CTEPH.

Trial purpose

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Key Participants Requirements

Sex

Both

Age

18 - 80 Years

  • - Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.
  • - All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Trial summary

Enrollment Goal
262
Trial Dates
February 2009 - June 2012
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gießen, 35392, Germany
Completed
München, 81377, Germany
Completed
Homburg, 66421, Germany
Completed
Köln, 50924, Germany
Completed
Greifswald, 17475, Germany
Completed
Hamburg, 20251, Germany
Withdrawn
Newcastle, NE7 7DN, United Kingdom
Withdrawn
Aurora, 80045, United States
Completed
Columbus, 43221, United States
Completed
Cleveland, 44195, United States
Completed
Baltimore, 21205, United States
Completed
La Jolla, 92093, United States
Withdrawn
Pittsburgh, 15212, United States
Completed
Hannover, 30625, Germany
Completed
Dresden, 01307, Germany
Completed
Leipzig, 04103, Germany
Completed
Heidelberg, 69126, Germany
Completed
Heidelberg, 69120, Germany
Completed
Cambridge, CB23 3RE, United Kingdom
Completed
Glasgow, G81 4DY, United Kingdom
Withdrawn
Fairfield, 45014, United States
Completed
Sacramento, 95817, United States
Withdrawn
Boston, 02115, United States
Completed
Miami, 33136, United States
Completed
Dallas, 75390, United States
Withdrawn
Birmingham, 35233, United States
Completed
BREST, F-29609, France
Completed
VANDOEUVRE LES NANCY, F-54500, France
Completed
Lille Cedex, 59037, France
Completed
Shinjuku-ku, 160-8582, Japan
Completed
Nagoya, 467-8602, Japan
Completed
Suita, 565-8565, Japan
Completed
Fukuoka, 812-8582, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Fujisawa, 251-0041, Japan
Completed
Suwa, 392-8510, Japan
Completed
Toronto, M5G 2N2, Canada
Completed
LEUVEN, 3000, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Withdrawn
NIEUWEGEIN, 3435 CM, Netherlands
Completed
Hopital Antoine BeclereClamart Cedex, 92141, France
Withdrawn
MONTPELLIER, 34059, France
Completed
Caen, 14033, France
Withdrawn
GRENOBLE Cedex 09, 38043, France
Withdrawn
Wroclaw, 51-124, Poland
Completed
Otwock, 05-400, Poland
Completed
Krakow, 31-202, Poland
Completed
Sendai, 980-8574, Japan
Completed
Chiba, 260-8677, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Pavia, 27100, Italy
Withdrawn
Roma, 00161, Italy
Completed
Madrid, 28041, Spain
Completed
Barcelona, 08036, Spain
Completed
Montreal, H3T 1E2, Canada
Completed
Amsterdam, 1081 HV, Netherlands
Completed
Aarhus N, 8200, Denmark
Completed
Vseobecna fakultni nemocnicePraha 2, 12808, Czech Republic
Withdrawn
Petah Tikva, 4941492, Israel
Completed
PRAHRAN, 3181, Australia
Withdrawn
Buenos Aires, C1039AAO, Argentina
Completed
Innsbruck, 6020, Austria
Completed
Istanbul, 34093, Turkey
Withdrawn
São Paulo, 05403-000, Brazil
Completed
São Paulo, 04020-050, Brazil
Completed
Rio de Janeiro, 21941-913, Brazil
Completed
St. Petersburg, 197341, Russian Federation
Completed
Beijing, 100037, China
Completed
Qingdao, 266003, China
Completed
Calgary, T1Y 6J4, Canada
Completed
Monterrey, 64020, Mexico
Completed
Monterrey, 64460, Mexico
Completed
Querétaro, 38000, Mexico
Withdrawn
Camperdown, 2050, Australia
Withdrawn
Herston, 4029, Australia
Withdrawn
Auchenflower, 4066, Australia
Completed
Coimbra, 3000-075, Portugal
Withdrawn
Porto, 4099-001, Portugal
Completed
Wien, 1090, Austria
Completed
Ankara, Turkey
Completed
Izmir, 35040, Turkey
Completed
Porto Alegre, 90020 090, Brazil
Completed
Bratislava 37, 833 48, Slovakia
Completed
Shanghai, 200433, China
Completed
Beijing, 100038, China
Completed
Seoul, 138-736, Korea, Republic Of
Withdrawn
Kaohsiung, 833, Taiwan
Completed
Beijing, 100020, China
Completed
Seoul, 06351, Korea, Republic Of
Completed
Zürich, 8091, Switzerland
Completed
Taipei, 100, Taiwan
Withdrawn
Dublin, D07 R2WY, Ireland
Withdrawn
Houston, 77030, United States
Completed
Shinjuku-ku, 162-8655, Japan
Completed
Seto, 489-8642, Japan
Completed
London, N6A 4G5, Canada
Completed
Novosibirsk, 630055, Russian Federation
Withdrawn
Providence, 02903, United States
Completed
Rouen, 76031, France
Withdrawn
Tours, 37000, France
Withdrawn
Gainesville, 32610, United States
Withdrawn
Baltimore, 21201, United States
Withdrawn
Boston, 02114, United States
Withdrawn
Murray, 84107, United States
Completed
Boston, 02118, United States
Withdrawn
Capital Federal, Argentina
Completed
Iowa City, 52242, United States
Completed
Würzburg, 97074, Germany
Withdrawn
Rochester, 55905, United States
Completed
Kitakyushu, 802-8555, Japan
Withdrawn
Weston, 33331, United States
Withdrawn
Isehara, 259-1193, Japan
Completed
Mexico D.F., 14080, Mexico
Withdrawn
Guadalajara, 44670, Mexico
Completed
London, W12 0HS, United Kingdom
Withdrawn
Regensburg, 93053, Germany
Withdrawn
AMSTERDAM, 1091 AC, Netherlands
Withdrawn
Lisboa, 1649-035, Portugal
Completed
Ottawa, K1Y 4W7, Canada
Completed
Komatsu, 923-8560, Japan
Completed
Corrientes, 3400, Argentina
Completed
PESSAC, 33604, France
Withdrawn
Hamilton, L8L 2X2, Canada
Completed
Kawasaki, 216-8511, Japan
Completed
NICE, 06200, France
Withdrawn
London, SW3 6NP, United Kingdom
Withdrawn
BESANCON, 25030, France
Withdrawn
Rochester, 14642, United States

Primary Outcome

  • 6 minutes walking distance (6MWD) - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Pulmonary vascular resistance (PVR) - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    enhanced_encryption
    Safety Issue:
    No
  • N-terminal prohormone of brain natriuretic peptide (NT-proBNP) - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    enhanced_encryption
    Safety Issue:
    No
  • World Health Organization (WHO) functional class - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of particpants with clinical worsening
    date_rangeTime Frame:
    At week 16
    enhanced_encryption
    Safety Issue:
    No
  • Borg CR 10 scale - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    enhanced_encryption
    Safety Issue:
    No
  • EQ-5D utility score - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    enhanced_encryption
    Safety Issue:
    No
  • Living with pulmonary hypertension (LPH) questionnaire - Change from baseline to week 16
    date_rangeTime Frame:
    Baseline and week 16
    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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2