check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

16097

ClinicalTrials.gov Identifier:

NCT01784562

EudraCT Number:

2012-002104-40

EU CT Number:

Not Available
Riociguat in patients with chronic thromboembolic pulmonary hypertension (CTEPH)

Trial purpose

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

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 other than Dana Point Classification Group 4
    - Operable patients listed for PEA (Pulmonary Endarterectomy)

Trial summary

Enrollment Goal
N/A
Trial Dates
null - Today
Phase
N/A
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Sacramento, 95817, United States
Completed
Aurora, 80045, United States
Completed
Pittsburgh, 15212, United States
Completed
Boston, 02118, United States
Completed
Iowa City, 52242-1089, United States
Completed
Cleveland, 44195, United States
Completed
Boston, 02111, United States
Completed
Ann Arbor, 48109, United States
Completed
Weston, 33331, United States
Completed
New York, 10032, United States
Completed
Columbus, 43221, United States
Terminated
Fairfield, 45014, United States
Completed
Aarhus N, 8200, Denmark
Completed
Praha 2, 12808, Czech Republic
Terminated
Houston, 77030, United States
Completed
El Paso, 79902, United States
Terminated
Tucson, 85724, United States
Completed
Coimbra, 3000-075, Portugal
Terminated
Lisboa, 1649-035, Portugal
Completed
Almada, 2801-951, Portugal
Terminated
Lisboa, 1169-024, Portugal
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
LEUVEN, 3000, Belgium
Terminated
Umeå, 901 85, Sweden
Completed
Lund, 221 85, Sweden
Completed
Hannover, 30625, Germany
Completed
Heidelberg, 69126, Germany
Completed
Gießen, 35392, Germany
Terminated
München, 81377, Germany
Completed
Köln, 50924, Germany
Completed
Dresden, 01307, Germany
Completed
Hamburg, 20246, Germany
Completed
Leipzig, 04103, Germany
Completed
Würzburg, 97074, Germany
Terminated
Greifswald, 17475, Germany
Completed
Regensburg, 93042, Germany
Completed
LE KREMLIN-BICETRE, 94275, France
Completed
Rouen, 76031, France
Completed
BREST, F-29609, France
Completed
MONTPELLIER, 34059, France
Completed
Pessac, 33604, France
Terminated
BESANCON, 25030, France
Completed
Bron, 69500, France
Completed
VANDOEUVRE LES NANCY, 54511, France
Completed
Madrid, 28041, Spain
Completed
Barcelona, 08036, Spain
Completed
Izmir, 34098, Turkey
Completed
Izmir, 35100, Turkey
Completed
Ankara, Turkey
Completed
St. Petersburg, 197341, Russia
Terminated
Novosibirsk, 630055, Russia
Completed
Pavia, 27100, Italy
Completed
Roma, 00161, Italy
Completed
Trieste, 34149, Italy
Completed
Montreal, H3T 1E2, Canada
Terminated
Calgary, T1Y 6J4, Canada
Terminated
London, N6C 2R5, Canada
Completed
Ottawa, K1Y 4W7, Canada
Terminated
Toronto, M5G 2C4, Canada
Terminated
Linköping, 581 85, Sweden
Terminated
St. Gallen, 9007, Switzerland
Completed
Zürich, 8091, Switzerland
Terminated
Lausanne, 1011, Switzerland
Terminated
La Jolla, 92037, United States
Completed
Providence, 02903-4900, United States
Terminated
Omaha, 68131, United States
Completed
Caen, 14033, France
Completed
Bern, 3010, Switzerland
Completed
Dallas, 75390, United States
Completed
Istanbul, 34-300, Turkey
Terminated
Istanbul, 34304, Turkey
Completed
Istanbul, 34-390, Turkey
Completed
AMSTERDAM, 1081 HV, Netherlands
Completed
NIEUWEGEIN, 3435 CM, Netherlands
Completed
Wien, 1090, Austria
Completed
Innsbruck, 6020, Austria
Completed
Baltimore, 21201-1595, United States
Terminated
Chicago, 60637, United States
Completed
ROTTERDAM, 3015 CE, Netherlands
Terminated
Philadelphia, 19104, United States
Terminated
Newark, 07112, United States
Terminated
Los Angeles, 90073, United States
Terminated
Sendai, 980-8574, Japan
Terminated
Chiba, 260-8677, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Terminated
Nagoya, 467-8602, Japan
Completed
Graz, 8036, Austria
Terminated
Graz, 8036, Austria
Completed
Cambridge, CB23 3RE, United Kingdom
Completed
Glasgow, G81 4DY, United Kingdom
Completed
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Sheffield, S10 2JF, United Kingdom
Completed
Homburg, 66421, Germany
Completed
Monterrey, 64718, Mexico
Completed
México D.F., 14080, Mexico
Withdrawn
DIME Clinica Neurocardiovascular S.A.Cali, Colombia
Withdrawn
Fundación Neumológica ColombianaBogotá, Colombia
Withdrawn
Fundación Clínica ShaioBogotá, Colombia
Withdrawn
Hospital Universitario de San IgnacioSanta Fe de Bogotá, Colombia
Completed
Mexico. D.F., 14000, Mexico
Withdrawn
Centro Especializado en Enfermedades Pulmonares S.A.SBogotá, Colombia
Completed
Sevilla, 41013, Spain
Completed
Barcelona, 08035, Spain
Terminated
Barcelona, 08036, Spain

Trial design

An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial
Trial Type
Expanded Access
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional 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 information about studies related to Bayer Healthcare products conducted in EuropeClick here to find results for studies related to Bayer Healthcare products.