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

EU CT Number:

Not Available

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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Sacramento, United States, 95817

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Aurora, United States, 80045

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Pittsburgh, United States, 15212

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Boston, United States, 02118

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Iowa City, United States, 52242-1089

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Cleveland, United States, 44195

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Boston, United States, 02111

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Ann Arbor, United States, 48109

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Weston, United States, 33331

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New York, United States, 10032

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Columbus, United States, 43221

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Fairfield, United States, 45014

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Aarhus N, Denmark, 8200

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Praha 2, Czech Republic, 12808

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Houston, United States, 77030

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El Paso, United States, 79902

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Tucson, United States, 85724

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Coimbra, Portugal, 3000-075

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Lisboa, Portugal, 1649-035

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Almada, Portugal, 2801-951

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Lisboa, Portugal, 1169-024

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BRUXELLES - BRUSSEL, Belgium, 1070

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LEUVEN, Belgium, 3000

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Umeå, Sweden, 901 85

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Lund, Sweden, 221 85

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Hannover, Germany, 30625

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Heidelberg, Germany, 69126

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Gießen, Germany, 35392

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München, Germany, 81377

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Köln, Germany, 50924

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Dresden, Germany, 01307

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Hamburg, Germany, 20246

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Leipzig, Germany, 04103

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Würzburg, Germany, 97074

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Greifswald, Germany, 17475

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Regensburg, Germany, 93042

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LE KREMLIN-BICETRE, France, 94275

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Rouen, France, 76031

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BREST, France, F-29609

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MONTPELLIER, France, 34059

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Pessac, France, 33604

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BESANCON, France, 25030

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Bron, France, 69500

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VANDOEUVRE LES NANCY, France, 54511

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Madrid, Spain, 28041

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Barcelona, Spain, 08036

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Izmir, Turkey, 34098

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Izmir, Turkey, 35100

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Ankara, Turkey

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St. Petersburg, Russia, 197341

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Novosibirsk, Russia, 630055

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Pavia, Italy, 27100

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Roma, Italy, 00161

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Trieste, Italy, 34149

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Montreal, Canada, H3T 1E2

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Calgary, Canada, T1Y 6J4

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London, Canada, N6C 2R5

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Ottawa, Canada, K1Y 4W7

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Toronto, Canada, M5G 2C4

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Linköping, Sweden, 581 85

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St. Gallen, Switzerland, 9007

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Zürich, Switzerland, 8091

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Lausanne, Switzerland, 1011

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La Jolla, United States, 92037

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Providence, United States, 02903-4900

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Omaha, United States, 68131

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Caen, France, 14033

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Bern, Switzerland, 3010

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Dallas, United States, 75390

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Istanbul, Turkey, 34-300

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Istanbul, Turkey, 34304

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Istanbul, Turkey, 34-390

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AMSTERDAM, Netherlands, 1081 HV

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NIEUWEGEIN, Netherlands, 3435 CM

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Wien, Austria, 1090

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Innsbruck, Austria, 6020

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Baltimore, United States, 21201-1595

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Chicago, United States, 60637

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ROTTERDAM, Netherlands, 3015 CE

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Philadelphia, United States, 19104

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Newark, United States, 07112

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Los Angeles, United States, 90073

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Sendai, Japan, 980-8574

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Chiba, Japan, 260-8677

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Bunkyo-ku, Japan, 113-8655

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Nagoya, Japan, 467-8602

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Graz, Austria, 8036

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Graz, Austria, 8036

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Cambridge, United Kingdom, CB23 3RE

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Glasgow, United Kingdom, G81 4DY

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Newcastle Upon Tyne, United Kingdom, NE7 7DN

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Sheffield, United Kingdom, S10 2JF

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Homburg, Germany, 66421

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Monterrey, Mexico, 64718

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México D.F., Mexico, 14080

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Mexico. D.F., Mexico, 14000

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Sevilla, Spain, 41013

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Barcelona, Spain, 08035

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Barcelona, Spain, 08036

For details, please refer to trial results

Additional Information