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A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. (CHEST-1)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Riociguat (Adempas, BAY63-2521)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Chronic thromboembolic pulmonary hypertension, PH, soluble Guanylate Cyclase Stimulator, sGC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Sites / Locations

  • Vseobecna fakultni nemocnice
  • Hopital Antoine Beclere

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Riociguat (Adempas, BAY63-2521)_individual dose titration

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 16 weeks

Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks

Outcomes

Primary Outcome Measures

6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.

Secondary Outcome Measures

Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
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 16
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 16
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients 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; rescue endarterectomy; 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 16
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 16
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 16
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

First Posted
December 15, 2008
Last Updated
October 14, 2016
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00855465
Brief Title
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
Acronym
CHEST-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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 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 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Detailed Description
Adverse event data will be covered in Adverse events section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Chronic thromboembolic pulmonary hypertension, PH, soluble Guanylate Cyclase Stimulator, sGC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riociguat (Adempas, BAY63-2521)_individual dose titration
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 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Riociguat (Adempas, BAY63-2521)
Intervention Description
BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo tid orally for 16 weeks
Primary Outcome Measure Information:
Title
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
Description
6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.
Time Frame
Baseline and week 16
Secondary Outcome Measure Information:
Title
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
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 16
Title
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16
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 16
Title
World Health Organization (WHO) Functional Class - Change From Baseline to Week 16
Description
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients 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 16
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; rescue endarterectomy; 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 16
Title
Borg CR 10 Scale - Change From Baseline to Week 16
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 16
Title
EQ-5D Utility Score - Change From Baseline to Week 16
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 16
Title
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16
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 16
Other Pre-specified Outcome Measures:
Title
All Caused Mortality
Description
All cause mortality (including cardiovascular mortality) was one component of the composite endpoint "time to clinical worsening".
Time Frame
At visit 6 (week 16)
Title
Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16
Description
Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.
Time Frame
Baseline and week 16
Title
Cardiac Index (CI) - Change From Baseline to Week 16
Description
The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject's height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2)
Time Frame
Baseline and week 16
Title
Systolic Blood Pressure (SBP) - Change From Baseline to Week 16
Description
Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 - 180 mmHg.
Time Frame
Baseline and week 16
Title
Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16
Description
Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg.
Time Frame
Baseline and week 16
Title
Heart Rate (HR) - Change From Baseline to Week 16
Description
Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest.
Time Frame
Baseline and week 16
Title
Alanine Aminotransferase (ALT) - Change From Baseline to Week 16
Description
Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L.
Time Frame
Baseline and week 16
Title
Aspartate Aminotransferase (AST) - Change From Baseline to Week 16
Description
Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L.
Time Frame
Baseline and week 16
Title
Alkaline Phosphatase (AP) - Change From Baseline to Week 16
Description
Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females)
Time Frame
Baseline and week 16
Title
Bilirubin - Change From Baseline to Week 16
Description
Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL
Time Frame
Baseline and week 16
Title
Creatinine - Change From Baseline to Week 16
Description
Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females)
Time Frame
Baseline and week 16
Title
Creatinine Clearance - Change From Baseline to Week 16
Description
Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females)
Time Frame
Baseline and week 16
Title
Creatine Kinase (CK) - Change From Baseline to Week 16
Description
Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females)
Time Frame
Baseline and week 16
Title
Erythrocytes (RBC) - Change From Baseline to Week 16
Description
Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females)
Time Frame
Baseline and week 16
Title
Leukocytes (WBC) - Change From Baseline to Week 16
Description
Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L
Time Frame
Baseline and week 16
Title
Lymphocytes - Change From Baseline to Week 16
Description
Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L
Time Frame
Baseline and week 16
Title
Neutrophils - Change From Baseline to Week 16
Description
Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L
Time Frame
Baseline and week 16
Title
Hemoglobin - Change From Baseline to Week 16
Description
Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females)
Time Frame
Baseline and week 16
Title
Hematocrit - Change From Baseline to Week 16
Description
Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females)
Time Frame
Baseline and week 16
Title
Potassium - Change From Baseline to Week 16
Description
Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L
Time Frame
Baseline and week 16
Title
Urate - Change From Baseline to Week 16
Description
Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females)
Time Frame
Baseline and week 16
Title
Urea (BUN) - Change From Baseline to Week 16
Description
Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL
Time Frame
Baseline and week 16
Title
Cystatin C - Change From Baseline to Week 16
Description
Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL
Time Frame
Baseline and week 16
Title
Triacylglycerol Lipase - Change From Baseline to Week 16
Description
Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L
Time Frame
Baseline and week 16
Title
Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16
Description
Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.
Time Frame
Baseline and week 16
Title
Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16
Description
Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.
Time Frame
Baseline and week 16
Title
Oxygen Saturation (SaO2) - Change From Baseline to Week 16
Description
Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.
Time Frame
Baseline and week 16
Title
Mean PR Duration (PRmean) - Change From Baseline to Week 16
Description
PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and week 16
Title
Mean QRS Duration (QRSmean) - Change From Baseline to Week 16
Description
QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and week 16
Title
Mean QT Duration (QTmean) - Change From Baseline to Week 16
Description
QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and week 16
Title
Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16
Description
Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and week 16
Title
Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16
Description
Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and week 16
Title
Mean RR Duration (RRmean) - Change From Baseline to Week 16
Description
RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.
Time Frame
Baseline and week 16
Title
Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16
Description
Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position
Time Frame
Baseline and week 16

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 CTEPH either inoperable or with persistent or recurrent PH after surgery. Exclusion Criteria: All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.
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
La Jolla
State/Province
California
ZIP/Postal Code
92093
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
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
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
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
City
Capital Federal
Country
Argentina
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
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
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
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
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
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
City
Beijing
ZIP/Postal Code
100020
Country
China
City
Beijing
ZIP/Postal Code
100037
Country
China
City
Beijing
ZIP/Postal Code
100038
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Vseobecna fakultni nemocnice
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
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Antoine Beclere
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
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
Vandoeuvre Les Nancy
ZIP/Postal Code
F-54500
Country
France
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
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
93053
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
20251
Country
Germany
City
Dublin
ZIP/Postal Code
DUBLIN 7
Country
Ireland
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-0041
Country
Japan
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Suwa
State/Province
Nagano
ZIP/Postal Code
392-8510
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
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
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
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
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
Bratislava 37
ZIP/Postal Code
833 48
Country
Slovakia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
City
Ankara
Country
Turkey
City
Istanbul
ZIP/Postal Code
34-390
Country
Turkey
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
City
Glasgow
State/Province
West Dunbartonshire
ZIP/Postal Code
G81 4DY
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23883377
Citation
Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.
Results Reference
result
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
27067478
Citation
Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.
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
26910470
Citation
Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. doi: 10.4143/crt.2015.278. Epub 2016 Feb 24.
Results Reference
result
PubMed Identifier
27106231
Citation
Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. doi: 10.1007/s00535-016-1204-2. Epub 2016 Apr 22.
Results Reference
result
PubMed Identifier
28011757
Citation
Kim NH, D'Armini AM, Grimminger F, Grunig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.
Results Reference
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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

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A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

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