Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
EAS
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
2 other identifiers
expanded_access
N/A
20 countries
102
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2013
CompletedJanuary 6, 2016
January 1, 2016
February 4, 2013
January 5, 2016
Conditions
Keywords
Interventions
Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)
Eligibility Criteria
You may qualify if:
- \- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
You may not qualify if:
- All types of pulmonary hypertension other than Dana Point Classification Group 4
- Operable patients listed for PEA (Pulmonary Endarterectomy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (102)
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Tucson, Arizona, 85724, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90073, United States
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Sacramento, California, 95817, United States
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Aurora, Colorado, 80045, United States
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Weston, Florida, 33331, United States
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Chicago, Illinois, 60637, United States
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Iowa City, Iowa, 52242-1089, United States
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Baltimore, Maryland, 21201-1595, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02118, United States
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Ann Arbor, Michigan, 48109, United States
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Omaha, Nebraska, 68131, United States
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Newark, New Jersey, 07112, United States
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New York, New York, 10032, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43221, United States
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Fairfield, Ohio, 45014, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Providence, Rhode Island, 02903-4900, United States
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Dallas, Texas, 75390, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77030, United States
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Graz, Styria, 8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Vienna, Vienna, 1090, Austria
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Bruxelles - Brussel, 1070, Belgium
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Leuven, 3000, Belgium
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Calgary, Alberta, T1Y 6J4, Canada
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London, Ontario, N6C 2R5, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Bogotá, Bogota D.C., Colombia
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Bogotá, Cundinamarca, Colombia
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Cali, Valle del Cauca Department, Colombia
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Bogotá, Colombia
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Santa Fé, Colombia
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Prague, 12808, Czechia
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Aarhus N, 8200, Denmark
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Besançon, 25030, France
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Brest, F-29609, France
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Bron, 69500, France
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Caen, 14033, France
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Le Kremlin-Bicêtre, 94275, France
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Montpellier, 34059, France
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Pessac, 33604, France
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Rouen, 76031, France
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Vandœuvre-lès-Nancy, 54511, France
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Heidelberg, Baden-Wurttemberg, 69126, Germany
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München, Bavaria, 81377, Germany
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Regensburg, Bavaria, 93042, Germany
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Würzburg, Bavaria, 97074, Germany
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Hamburg, Hamburg, 20246, Germany
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Giessen, Hesse, 35392, Germany
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Hanover, Lower Saxony, 30625, Germany
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Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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Cologne, North Rhine-Westphalia, 50924, Germany
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Homburg, Saarland, 66421, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04103, Germany
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Pavia, 27100, Italy
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Roma, 00161, Italy
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Trieste, 34149, Italy
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Nagoya, Aichi-ken, 467-8602, Japan
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Chiba, Chiba, 260-8677, Japan
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Sendai, Miyagi, 980-8574, Japan
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Bunkyo-ku, Tokyo, 113-8655, Japan
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Mexico City, Mexico City, 14000, Mexico
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México D.F., Mexico City, 14080, Mexico
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Monterrey, Nuevo León, 64718, Mexico
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Amsterdam, 1081 HV, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Coimbra, Coimbra District, 3000-075, Portugal
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Lisbon, Lisbon District, 1649-035, Portugal
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Almada, 2801-951, Portugal
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Lisbon, 1169-024, Portugal
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Novosibirsk, 630055, Russia
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Saint Petersburg, 197341, Russia
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Madrid, Madrid, 28041, Spain
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Seville, Sevilla, 41013, Spain
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Linköping, 581 85, Sweden
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Lund, 221 85, Sweden
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Umeå, 901 85, Sweden
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Bern, Canton of Bern, 3010, Switzerland
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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
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Lausanne, Canton of Vaud, 1011, Switzerland
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Zurich, Canton of Zurich, 8091, Switzerland
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Ankara, Turkey (Türkiye)
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Istanbul, 34-300, Turkey (Türkiye)
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Istanbul, 34-390, Turkey (Türkiye)
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Istanbul, 34304, Turkey (Türkiye)
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Izmir, 34098, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Cambridge, Cambridgeshire, CB23 3RE, United Kingdom
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Sheffield, South Yorkshire, S10 2JF, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
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Glasgow, West Dunbartonshire, G81 4DY, United Kingdom
Related Publications (1)
McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grunig E, Ulrich S, Rosenkranz S, Gomez Sanchez MA, Pulido T, Pepke-Zaba J, Barbera JA, Hoeper MM, Vachiery JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.
PMID: 29282032DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Last Updated
January 6, 2016
Record last verified: 2016-01