Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00910429
Registration number
NCT00910429
Ethics application status
Date submitted
27/05/2009
Date registered
29/05/2009
Date last updated
7/11/2023
Titles & IDs
Public title
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Query!
Scientific title
Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Query!
Secondary ID [1]
0
0
2008-003539-19
Query!
Secondary ID [2]
0
0
11349
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CHEST-2
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Experimental: Arm 1 -
Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Query!
Assessment method [1]
0
0
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Query!
Timepoint [1]
0
0
From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years
Query!
Primary outcome [2]
0
0
Number of Participants With Death
Query!
Assessment method [2]
0
0
Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.
Query!
Timepoint [2]
0
0
From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
Query!
Assessment method [1]
0
0
Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Query!
Timepoint [1]
0
0
From baseline to Termination visit, up to 10 years
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
Query!
Assessment method [2]
0
0
Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Query!
Timepoint [2]
0
0
From baseline to Termination visit, up to 10 years
Query!
Secondary outcome [3]
0
0
Change From Baseline of Hemoglobin in Hematology and Coagulation
Query!
Assessment method [3]
0
0
Hemoglobin is standard Hematology and coagulation parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Query!
Timepoint [3]
0
0
From baseline to Termination visit, up to 10 years
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Query!
Assessment method [4]
0
0
Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Query!
Timepoint [4]
0
0
From baseline to Termination visit, up to 10 years
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Query!
Assessment method [5]
0
0
Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Query!
Timepoint [5]
0
0
From baseline to Termination visit, up to 10 years
Query!
Secondary outcome [6]
0
0
Change From Baseline of Urate in Clinical Chemistry
Query!
Assessment method [6]
0
0
Urate is standard clinical chemistry parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study.
Query!
Timepoint [6]
0
0
From baseline to Termination visit, up to 10 years
Query!
Eligibility
Key inclusion criteria
* Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/08/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
237
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
- Prahran
Query!
Recruitment postcode(s) [1]
0
0
3181 - Prahran
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Iowa
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Ohio
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Texas
Query!
Country [7]
0
0
Argentina
Query!
State/province [7]
0
0
Corrientes
Query!
Country [8]
0
0
Austria
Query!
State/province [8]
0
0
Wien
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Bruxelles - Brussel
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Rio Grande Do Sul
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Sao Paulo
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Rio de Janeiro
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Alberta
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Beijing
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Shanghai
Query!
Country [19]
0
0
Czechia
Query!
State/province [19]
0
0
Praha 2
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Aarhus N
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Brest
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Le Kremlin Bicetre Cedex
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Rouen
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Vandoeuvre Les Nancy
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Baden-Württemberg
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Bayern
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Hessen
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Niedersachsen
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Nordrhein-Westfalen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Saarland
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Sachsen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Hamburg
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Petach Tikva
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Lombardia
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Aichi
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Fukuoka
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Ishikawa
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Kanagawa
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Miyagi
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Nagano
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Tokyo
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Chiba
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Seoul
Query!
Country [44]
0
0
Mexico
Query!
State/province [44]
0
0
Nuevo Leon
Query!
Country [45]
0
0
Mexico
Query!
State/province [45]
0
0
Mexico D.F.
Query!
Country [46]
0
0
Mexico
Query!
State/province [46]
0
0
Querétaro
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Krakow
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Otwock
Query!
Country [49]
0
0
Portugal
Query!
State/province [49]
0
0
Coimbra
Query!
Country [50]
0
0
Portugal
Query!
State/province [50]
0
0
Lisboa
Query!
Country [51]
0
0
Russian Federation
Query!
State/province [51]
0
0
Novosibirsk
Query!
Country [52]
0
0
Russian Federation
Query!
State/province [52]
0
0
St. Petersburg
Query!
Country [53]
0
0
Slovakia
Query!
State/province [53]
0
0
Bratislava 37
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Barcelona
Query!
Country [55]
0
0
Switzerland
Query!
State/province [55]
0
0
Zürich
Query!
Country [56]
0
0
Taiwan
Query!
State/province [56]
0
0
Taipei
Query!
Country [57]
0
0
Turkey
Query!
State/province [57]
0
0
Ankara
Query!
Country [58]
0
0
Turkey
Query!
State/province [58]
0
0
Istanbul
Query!
Country [59]
0
0
Turkey
Query!
State/province [59]
0
0
Izmir
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Cambridgeshire
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
West Dunbartonshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00910429
Query!
Trial related presentations / publications
Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28. Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1. 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. 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. 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/29/NCT00910429/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT00910429/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00910429
Download to PDF