Clinical trial NCT01784562: Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hypertension, Pulmonary
Keywords: Chronic thromboembolic pulmonary hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-02-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Weston
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Bruxelles - Brussel
country: Belgium
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Bogotá
country: Colombia
state: Cundinamarca
city: Bogotá
country: Colombia
state: Distrito Capital de Bogotá
city: Cali
country: Colombia
state: Valle del Cauca
city: Bogotá
country: Colombia
city: Santa Fe de Bogotá
country: Colombia
city: Praha 2
country: Czech Republic
city: Aarhus N
country: Denmark
city: Besancon
country: France
city: Brest
country: France
city: Bron
country: France
city: Caen
country: France
city: Le Kremlin-bicetre
country: France
city: Montpellier
country: France
city: Pessac
country: France
city: Rouen
country: France
city: Vandoeuvre Les Nancy
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Würzburg
country: Germany
state: Bayern
city: Gießen
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
state: Niedersachsen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Homburg
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Pavia
country: Italy
city: Roma
country: Italy
city: Trieste
country: Italy
city: Nagoya
country: Japan
state: Aichi
city: Sendai
country: Japan
state: Miyagi
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiba
country: Japan
city: Mexico. D.F.
country: Mexico
state: Distrito Federal
city: México D.F.
country: Mexico
state: Distrito Federal
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Amsterdam
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Almada
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Novosibirsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Linköping
country: Sweden
city: Lund
country: Sweden
city: Umeå
country: Sweden
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Lausanne
country: Switzerland
state: Vaud
city: Bern
country: Switzerland
city: Zürich
country: Switzerland
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Sheffield
country: United Kingdom
state: South Yorkshire
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: Glasgow
country: United Kingdom
state: West Dunbartonshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.