check_circleStudy Completed
pulmonary arterial hypertension
Bayer Identifier:
18588
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy
Trial purpose
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
Key Participants Requirements
Sex
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
225Trial Dates
January 2017 - March 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Adempas (Riociguat, BAY63-2521)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Köln, 50937, Germany | |
Completed | Gießen, 35390, Germany | |
Completed | Hannover, 30625, Germany | |
Completed | München, 81377, Germany | |
Completed | Leipzig, 04103, Germany | |
Completed | Heidelberg, 69126, Germany | |
Completed | Hamburg, 20246, Germany | |
Completed | Clydebank, G81 4DY, United Kingdom | |
Completed | London, SW3 6NP, United Kingdom | |
Completed | Le Kremlin-Bicêtre, 94270, France | |
Completed | Rouen, 76031, France | |
Completed | Pavia, 27100, Italy | |
Completed | Roma, 00161, Italy | |
Completed | Barcelona, 08036, Spain | |
Completed | Barcelona, 08035, Spain | |
Withdrawn | BRUXELLES - BRUSSEL, 1070, Belgium | |
Completed | AMSTERDAM, 1081 HV, Netherlands | |
Completed | NIJMEGEN, 6500HB, Netherlands | |
Completed | Coimbra, 3000-075, Portugal | |
Completed | Lisboa, 1649-035, Portugal | |
Withdrawn | Wien, 1090, Austria | |
Completed | Istanbul, 34-300, Turkey | |
Completed | Chaidari, 124 62, Greece | |
Completed | Thessaloniki, 57010, Greece | |
Completed | Seoul, 03722, Korea, Republic Of | |
Withdrawn | Madrid, 28041, Spain | |
Withdrawn | Barcelona, 08003, Spain | |
Completed | Mexico D.F., 14080, Mexico | |
Withdrawn | Innsbruck, 6020, Austria | |
Completed | Graz, 8036, Austria | |
Completed | Izmir, 34098, Turkey | |
Completed | Thessaloniki, 546 36, Greece | |
Completed | Seoul, 138-736, Korea, Republic Of | |
Completed | Seoul, 135-710, Korea, Republic Of | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Toledo, 45004, Spain | |
Completed | Dresden, 01307, Germany | |
Completed | Homburg, 66421, Germany | |
Completed | Würzburg, 97074, Germany | |
Completed | München, 80639, Germany | |
Completed | Nagoya, 467-8602, Japan | |
Completed | Sendai, 980-8574, Japan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Palermo, 90127, Italy | |
Withdrawn | Toronto, M5G 2N2, Canada | |
Withdrawn | Vancouver, V5Z 1M9, Canada | |
Completed | Montreal, H3T 1E2, Canada | |
Withdrawn | Calgary, T1Y 6J4, Canada | |
Completed | LEUVEN, 3000, Belgium | |
Completed | Culiacan, 80020, Mexico | |
Completed | Aarhus N, 8200, Denmark | |
Completed | Almada, 2801-951, Portugal | |
Completed | Taipei, 10016, Taiwan | |
Completed | Kaoshiung, 81346, Taiwan | |
Withdrawn | Cambridge, CB23 3RE, United Kingdom | |
Completed | London, NW3 2QG, United Kingdom | |
Completed | Sacramento, 95817, United States | |
Withdrawn | Columbus, 43210-1240, United States | |
Completed | Dallas, 75390, United States | |
Withdrawn | Boston, 02118, United States | |
Withdrawn | Boston, 02111, United States | |
Withdrawn | Falls Church, 22042, United States | |
Withdrawn | Milwaukee, 53215, United States | |
Withdrawn | Pittsburgh, 15212, United States | |
Completed | Weston, 33331, United States | |
Completed | Tucson, 85724, United States | |
Withdrawn | St, Louis, 63110, United States | |
Completed | Rochester, 14623, United States | |
Completed | New York, 10003, United States | |
Completed | Cleveland, 44195, United States | |
Completed | Louisville, 40202, United States | |
Withdrawn | Boston, 02114-2696, United States | |
Withdrawn | Chicago, 60612, United States | |
Withdrawn | Seattle, 98195, United States | |
Completed | Nashville, 37232, United States | |
Completed | Detroit, 48202, United States | |
Completed | Kansas City, 66103, United States | |
Withdrawn | New Haven, 06520, United States | |
Withdrawn | Oak Lawn, 60453, United States | |
Completed | Newark, 07112, United States | |
Withdrawn | Chapel Hill, 27599, United States | |
Completed | Mineola, 11501, United States | |
Withdrawn | Lille Cedex, 59037, France | |
Withdrawn | GRENOBLE Cedex 09, 38043, France | |
Withdrawn | BESANCON, 25030, France | |
Withdrawn | Camperdown, 2050, Australia | |
Withdrawn | Chermside, 4032, Australia | |
Completed | Sao Paulo, 04023-061, Brazil | |
Withdrawn | Genève, 1205, Switzerland | |
Withdrawn | Zürich, 8091, Switzerland | |
Completed | Las Palmas de Gran Canaria, 35020, Spain | |
Completed | Phoenix, 85012, United States | |
Completed | Tainan, 704, Taiwan | |
Withdrawn | Ann Arbor, 48109-0330, United States | |
Completed | Lübeck, 23538, Germany | |
Completed | Praha 2, 12808, Czech Republic | |
Completed | Praha 4, 140 21, Czech Republic | |
Withdrawn | Rio de Janeiro, 21941-913, Brazil | |
Completed | Porto Alegre, 90050-170, Brazil | |
Completed | Belo Horizonte, 30130-100, Brazil | |
Completed | Sao Paulo, 05403-000, Brazil | |
Withdrawn | Brasília, 70840 901, Brazil | |
Completed | Belo Horizonte, 30441-070, Brazil | |
Completed | Sheffield, S10 2JF, United Kingdom | |
Completed | Berlin, 14050, Germany | |
Withdrawn | Orlando, 32803, United States | |
Completed | Blumenal, 89030-101, Brazil | |
Withdrawn | Salamanca, 37007, Spain | |
Completed | Napoli, 80131, Italy | |
Completed | Istanbul, 34093, Turkey | |
Completed | Ankara, 06100, Turkey | |
Withdrawn | Otwock, 05-400, Poland | |
Withdrawn | Lodz, 91-347, Poland | |
Completed | Wroclaw, 51-124, Poland | |
Completed | Orlando, 32803, United States | |
Completed | Troy, 48085, United States | |
Completed | Richmond, 23225, United States | |
Withdrawn | Madrid, 28034, Spain | |
Withdrawn | Bath, BA1 3NG, United Kingdom | |
Withdrawn | København Ø, 2100, Denmark |
Primary Outcome
- Efficacy (Y/N)The treatment is assessed efficient in case at least 2 out of the following 3 criteria were fulfilled •6 Minute Walking Distance increase by ≥ 10% or ≥ 30 m from baseline to Week 24 •World Health Organization Functional Class (WHO FC) I or II at Week 24 •N-terminal pro-brain natriuretic peptide (NT-proBNP) reduction ≥ 30% from baseline to Week 24 (NT-proBNP ratio Week 24/baseline ≤ 0.7) and in absence of the defined criteria of clinical worseningdate_rangeTime Frame:at Week 24enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in 6 Minute Walking Distance (6MWD) from baseline to 24 weeksdate_rangeTime Frame:Baseline and Week 24enhanced_encryptionNoSafety Issue:
- Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 24 weeksdate_rangeTime Frame:Baseline and Week 24enhanced_encryptionNoSafety Issue:
- Change in World Health Organization Functional Class (WHO FC) from baseline to 24 weeksdate_rangeTime Frame:Baseline and Week 24enhanced_encryptionNoSafety Issue:
- Change in clinical worsening from baseline to 24 weeksDefinition of clinical worsening: 1) Death of any cause 2) Hospitalization due to worsening PAH (adjudicated): - Non-elective hospitalization due to PAH, or - Initiation of intravenous/subcutaneous prostanoid therapy. 3) Disease progression (adjudicated): - 6MWD decrease ≥ 15% from baseline (2 measurements on 2 separate days), and - Worsening in WHO FC. OR - 6MWD decrease ≥ 15% (2 measurements on 2 separate days), and - Need of new PAH-targeted medication or decompensated right sided heart failure.date_rangeTime Frame:Baseline and Week 24enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe