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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002104-40 | EudraCT Number |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adempas (Riociguat, BAY63-2521) | Drug | 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.) |
Inclusion Criteria:
- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29282032 | Derived | 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. |
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| La Jolla |
| California |
| 92037 |
| United States |
| Los Angeles | California | 90073 | United States |
| Sacramento | California | 95817 | United States |
| Aurora | Colorado | 80045 | United States |
| Weston | Florida | 33331 | United States |
| Chicago | Illinois | 60637 | United States |
| Iowa City | Iowa | 52242-1089 | United States |
| Baltimore | Maryland | 21201-1595 | United States |
| Boston | Massachusetts | 02111 | United States |
| Boston | Massachusetts | 02118 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Omaha | Nebraska | 68131 | United States |
| Newark | New Jersey | 07112 | United States |
| New York | New York | 10032 | United States |
| Cleveland | Ohio | 44195 | United States |
| Columbus | Ohio | 43221 | United States |
| Fairfield | Ohio | 45014 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15212 | United States |
| Providence | Rhode Island | 02903-4900 | United States |
| Dallas | Texas | 75390 | United States |
| El Paso | Texas | 79902 | United States |
| Houston | Texas | 77030 | United States |
| Vienna | State of Vienna | 1090 | Austria |
| Graz | Styria | 8036 | Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Bruxelles - Brussel | 1070 | Belgium |
| Leuven | 3000 | Belgium |
| Calgary | Alberta | T1Y 6J4 | Canada |
| London | Ontario | N6C 2R5 | Canada |
| Ottawa | Ontario | K1Y 4W7 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Bogotá | Bogota D.C. | Colombia |
| Bogotá | Cundinamarca | Colombia |
| Cali | Valle del Cauca Department | Colombia |
| Bogotá | Colombia |
| Santa Fé | Colombia |
| Prague | 12808 | Czechia |
| Aarhus N | 8200 | Denmark |
| Besançon | 25030 | France |
| Brest | F-29609 | France |
| Bron | 69500 | France |
| Caen | 14033 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Montpellier | 34059 | France |
| Pessac | 33604 | France |
| Rouen | 76031 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| München | Bavaria | 81377 | Germany |
| Regensburg | Bavaria | 93042 | Germany |
| Würzburg | Bavaria | 97074 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Cologne | North Rhine-Westphalia | 50924 | Germany |
| Homburg | Saarland | 66421 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Pavia | 27100 | Italy |
| Roma | 00161 | Italy |
| Trieste | 34149 | Italy |
| Nagoya | Aichi-ken | 467-8602 | Japan |
| Chiba | Chiba | 260-8677 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Mexico City | Mexico City | 14000 | Mexico |
| México D.F. | Mexico City | 14080 | Mexico |
| Monterrey | Nuevo León | 64718 | Mexico |
| Amsterdam | 1081 HV | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| Rotterdam | 3015 CE | Netherlands |
| Coimbra | Coimbra District | 3000-075 | Portugal |
| Lisbon | Lisbon District | 1649-035 | Portugal |
| Almada | 2801-951 | Portugal |
| Lisbon | 1169-024 | Portugal |
| Novosibirsk | 630055 | Russia |
| Saint Petersburg | 197341 | Russia |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Linköping | 581 85 | Sweden |
| Lund | 221 85 | Sweden |
| Umeå | 901 85 | Sweden |
| Bern | Canton of Bern | 3010 | Switzerland |
| Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Lausanne | Canton of Vaud | 1011 | Switzerland |
| Zurich | Canton of Zurich | 8091 | Switzerland |
| Ankara | Turkey (Türkiye) |
| Istanbul | 34-300 | Turkey (Türkiye) |
| Istanbul | 34-390 | Turkey (Türkiye) |
| Istanbul | 34304 | Turkey (Türkiye) |
| Izmir | 34098 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| Glasgow | West Dunbartonshire | G81 4DY | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542595 | riociguat |
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