Trial Condition(s):

Hypertension, Pulmonary

Riociguat in patients with chronic thromboembolic pulmonary hypertension (CTEPH) (EAS)

Bayer Identifier:

16097

ClinicalTrials.gov Identifier:

NCT01784562

EudraCT Number:

2012-002104-40

Study Completed

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.

Inclusion Criteria
- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
Exclusion Criteria
- 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
N/A
black-arrow
N/A
Phase
N/A
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
N/A

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sacramento, United States, 95817

Status
Completed
 
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15212

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Iowa City, United States, 52242-1089

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02111

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Investigative Site

Weston, United States, 33331

Status
Completed
 
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43221

Status
Completed
 
Locations

Investigative Site

Fairfield, United States, 45014

Status
Terminated
 
Locations

Investigative Site

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Terminated
 
Locations

Investigative Site

El Paso, United States, 79902

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85724

Status
Terminated
 
Locations

Investigative Site

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1649-035

Status
Terminated
 
Locations

Investigative Site

Almada, Portugal, 2801-951

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1169-024

Status
Terminated
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Umeå, Sweden, 901 85

Status
Terminated
 
Locations

Investigative Site

Lund, Sweden, 221 85

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

Heidelberg, Germany, 69126

Status
Completed
 
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Terminated
 
Locations

Investigative Site

Köln, Germany, 50924

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
Locations

Investigative Site

Würzburg, Germany, 97074

Status
Completed
 
Locations

Investigative Site

Greifswald, Germany, 17475

Status
Terminated
 
Locations

Investigative Site

Regensburg, Germany, 93042

Status
Completed
 
Locations

Investigative Site

LE KREMLIN-BICETRE, France, 94275

Status
Completed
 
Locations

Investigative Site

Rouen, France, 76031

Status
Completed
 
Locations

Investigative Site

BREST, France, F-29609

Status
Completed
 
Locations

Investigative Site

MONTPELLIER, France, 34059

Status
Completed
 
Locations

Investigative Site

Pessac, France, 33604

Status
Completed
 
Locations

Investigative Site

BESANCON, France, 25030

Status
Terminated
 
Locations

Investigative Site

Bron, France, 69500

Status
Completed
 
Locations

Investigative Site

VANDOEUVRE LES NANCY, France, 54511

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28041

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Izmir, Turkey, 34098

Status
Completed
 
Locations

Investigative Site

Izmir, Turkey, 35100

Status
Completed
 
Locations

Investigative Site

Ankara, Turkey

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197341

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630055

Status
Terminated
 
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00161

Status
Completed
 
Locations

Investigative Site

Trieste, Italy, 34149

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T1Y 6J4

Status
Terminated
 
Locations

Investigative Site

London, Canada, N6C 2R5

Status
Terminated
 
Locations

Investigative Site

Ottawa, Canada, K1Y 4W7

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2C4

Status
Terminated
 
Locations

Investigative Site

Linköping, Sweden, 581 85

Status
Terminated
 
Locations

Investigative Site

St. Gallen, Switzerland, 9007

Status
Terminated
 
Locations

Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Lausanne, Switzerland, 1011

Status
Terminated
 
Locations

Investigative Site

La Jolla, United States, 92037

Status
Terminated
 
Locations

Investigative Site

Providence, United States, 02903-4900

Status
Completed
 
Locations

Investigative Site

Omaha, United States, 68131

Status
Terminated
 
Locations

Investigative Site

Caen, France, 14033

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
Locations

Investigative Site

Dallas, United States, 75390

Status
Completed
 
Locations

Investigative Site

Istanbul, Turkey, 34-300

Status
Completed
 
Locations

Investigative Site

Istanbul, Turkey, 34304

Status
Terminated
 
Locations

Investigative Site

Istanbul, Turkey, 34-390

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
Locations

Investigative Site

NIEUWEGEIN, Netherlands, 3435 CM

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21201-1595

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60637

Status
Terminated
 
Locations

Investigative Site

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Terminated
 
Locations

Investigative Site

Newark, United States, 07112

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90073

Status
Terminated
 
Locations

Investigative Site

Sendai, Japan, 980-8574

Status
Terminated
 
Locations

Investigative Site

Chiba, Japan, 260-8677

Status
Terminated
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 467-8602

Status
Terminated
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Terminated
 
Locations

Investigative Site

Cambridge, United Kingdom, CB23 3RE

Status
Completed
 
Locations

Investigative Site

Glasgow, United Kingdom, G81 4DY

Status
Completed
 
Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Investigative Site

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
Locations

Investigative Site

Homburg, Germany, 66421

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64718

Status
Completed
 
Locations

Investigative Site

México D.F., Mexico, 14080

Status
Completed
 
Locations

Investigative Site

Mexico. D.F., Mexico, 14000

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Terminated
 

For details, please refer to trial results

Additional Information