Back to resultsA Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (PATENT-1)
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Riociguat (Adempas, BAY63-2521)
Riociguat (Adempas, BAY63-2521)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary arterial hypertension, PH, Stimulator
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
- Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
Exclusion Criteria:
- All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
Sites / Locations
- Royal Hobart Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT
Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT
Placebo
Arm Description
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
Outcomes
Primary Outcome Measures
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
Secondary Outcome Measures
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12
The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12
N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
World Health Organization (WHO) Functional Class - Change From Baseline to Week 12
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.
Percentage of Participants With Clinical Worsening
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .
Borg CR 10 Scale - Change From Baseline to Week 12
The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
EQ-5D Utility Score - Change From Baseline to Week 12
EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12
The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00810693
Brief Title
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Acronym
PATENT-1
Official Title
Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary arterial hypertension, PH, Stimulator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT
Arm Type
Experimental
Arm Description
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Arm Title
Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT
Arm Type
Experimental
Arm Description
Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Riociguat (Adempas, BAY63-2521)
Intervention Description
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Riociguat (Adempas, BAY63-2521)
Intervention Description
BAY63-2521: 1.5mg tid orally for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo tid orally for 12 weeks
Primary Outcome Measure Information:
Title
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
Description
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12
Description
The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO
Time Frame
Baseline and week 12
Title
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12
Description
N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time Frame
Baseline and week 12
Title
World Health Organization (WHO) Functional Class - Change From Baseline to Week 12
Description
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.
Time Frame
Baseline and week 12
Title
Percentage of Participants With Clinical Worsening
Description
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .
Time Frame
At week 12
Title
Borg CR 10 Scale - Change From Baseline to Week 12
Description
The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
Time Frame
Baseline and week 12
Title
EQ-5D Utility Score - Change From Baseline to Week 12
Description
EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).
Time Frame
Baseline and week 12
Title
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12
Description
The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).
Time Frame
Baseline and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
Exclusion Criteria:
All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93721
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
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
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
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1120AAF
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Capital Federal
Country
Argentina
City
Vicente López
ZIP/Postal Code
1638
Country
Argentina
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
City
Innsbruck
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
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90020 090
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04012 180
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
21941-900
Country
Brazil
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
City
Beijing
ZIP/Postal Code
100020
Country
China
City
Beijing
ZIP/Postal Code
100037
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
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
Clamart Cedex
ZIP/Postal Code
92141
Country
France
City
GRENOBLE Cedex 09
ZIP/Postal Code
38043
Country
France
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Montpellier
ZIP/Postal Code
34059
Country
France
City
Nice
ZIP/Postal Code
06200
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Tours
ZIP/Postal Code
37000
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
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
Haidari
ZIP/Postal Code
124 62
Country
Greece
City
Kallithea / Athens
ZIP/Postal Code
17674
Country
Greece
City
Dublin
Country
Ireland
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34149
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20123
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
City
Asahikwa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0022
Country
Japan
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Tomigusuku
State/Province
Okinawa
ZIP/Postal Code
901-0243
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-0929
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
City
Mexico D.F.
ZIP/Postal Code
14080
Country
Mexico
City
Querétaro
ZIP/Postal Code
38000
Country
Mexico
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
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
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
City
Singapore
ZIP/Postal Code
168752
Country
Singapore
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
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Kaoshiung
ZIP/Postal Code
81346
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Ankara
Country
Turkey
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
City
Istanbul
ZIP/Postal Code
34304
Country
Turkey
City
Izmir
ZIP/Postal Code
35-100
Country
Turkey
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
City
Clydebank
State/Province
West Dunbartonshire
ZIP/Postal Code
G81 4DY
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23883383
Citation
Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.
Results Reference
result
PubMed Identifier
23883378
Citation
Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.
Results Reference
result
PubMed Identifier
26135803
Citation
Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.
Results Reference
result
PubMed Identifier
27326239
Citation
Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.
Results Reference
result
PubMed Identifier
27263466
Citation
Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.
Results Reference
result
PubMed Identifier
34353714
Citation
Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.
Results Reference
derived
PubMed Identifier
27457511
Citation
Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.
Results Reference
derived
PubMed Identifier
27162632
Citation
Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
We'll reach out to this number within 24 hrs