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Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)

Primary Purpose

Hypertension, Pulmonary

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Adempas (Riociguat, BAY63-2521)
Sponsored by
Bayer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Hypertension, Pulmonary focused on measuring Chronic thromboembolic pulmonary hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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)

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 4, 2013
Last Updated
January 5, 2016
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01784562
Brief Title
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Acronym
EAS
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
Chronic thromboembolic pulmonary hypertension

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adempas (Riociguat, BAY63-2521)
Intervention Description
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.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1089
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903-4900
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2R5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
City
Bogotá
State/Province
Distrito Capital de Bogotá
Country
Colombia
City
Cali
State/Province
Valle del Cauca
Country
Colombia
City
Bogotá
Country
Colombia
City
Santa Fe de Bogotá
Country
Colombia
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Brest
ZIP/Postal Code
F-29609
Country
France
City
Bron
ZIP/Postal Code
69500
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
City
Montpellier
ZIP/Postal Code
34059
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93042
Country
Germany
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97074
Country
Germany
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Trieste
ZIP/Postal Code
34149
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Mexico. D.F.
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
City
México D.F.
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Ankara
Country
Turkey
City
Istanbul
ZIP/Postal Code
34-300
Country
Turkey
City
Istanbul
ZIP/Postal Code
34-390
Country
Turkey
City
Istanbul
ZIP/Postal Code
34304
Country
Turkey
City
Izmir
ZIP/Postal Code
34098
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Glasgow
State/Province
West Dunbartonshire
ZIP/Postal Code
G81 4DY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29282032
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.
Results Reference
derived

Learn more about this trial

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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