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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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).
Secondary ID [1] 0 0
2008-003539-19
Secondary ID [2] 0 0
11349
Universal Trial Number (UTN)
Trial acronym
CHEST-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE)
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
Primary outcome [2] 0 0
Number of Participants With Death
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)
Secondary outcome [1] 0 0
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
Timepoint [1] 0 0
From baseline to Termination visit, up to 10 years
Secondary outcome [2] 0 0
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
Timepoint [2] 0 0
From baseline to Termination visit, up to 10 years
Secondary outcome [3] 0 0
Change From Baseline of Hemoglobin in Hematology and Coagulation
Timepoint [3] 0 0
From baseline to Termination visit, up to 10 years
Secondary outcome [4] 0 0
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Timepoint [4] 0 0
From baseline to Termination visit, up to 10 years
Secondary outcome [5] 0 0
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Timepoint [5] 0 0
From baseline to Termination visit, up to 10 years
Secondary outcome [6] 0 0
Change From Baseline of Urate in Clinical Chemistry
Timepoint [6] 0 0
From baseline to Termination visit, up to 10 years

Eligibility
Key inclusion criteria
- Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2019
Sample size
Target
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Corrientes
Country [8] 0 0
Austria
State/province [8] 0 0
Wien
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles - Brussel
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio Grande Do Sul
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Paulo
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio de Janeiro
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha 2
Country [20] 0 0
Denmark
State/province [20] 0 0
Aarhus N
Country [21] 0 0
France
State/province [21] 0 0
Brest
Country [22] 0 0
France
State/province [22] 0 0
Le Kremlin Bicetre Cedex
Country [23] 0 0
France
State/province [23] 0 0
Rouen
Country [24] 0 0
France
State/province [24] 0 0
Vandoeuvre Les Nancy
Country [25] 0 0
Germany
State/province [25] 0 0
Baden-Württemberg
Country [26] 0 0
Germany
State/province [26] 0 0
Bayern
Country [27] 0 0
Germany
State/province [27] 0 0
Hessen
Country [28] 0 0
Germany
State/province [28] 0 0
Niedersachsen
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein-Westfalen
Country [30] 0 0
Germany
State/province [30] 0 0
Saarland
Country [31] 0 0
Germany
State/province [31] 0 0
Sachsen
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Israel
State/province [33] 0 0
Petach Tikva
Country [34] 0 0
Italy
State/province [34] 0 0
Lombardia
Country [35] 0 0
Japan
State/province [35] 0 0
Aichi
Country [36] 0 0
Japan
State/province [36] 0 0
Fukuoka
Country [37] 0 0
Japan
State/province [37] 0 0
Ishikawa
Country [38] 0 0
Japan
State/province [38] 0 0
Kanagawa
Country [39] 0 0
Japan
State/province [39] 0 0
Miyagi
Country [40] 0 0
Japan
State/province [40] 0 0
Nagano
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Japan
State/province [42] 0 0
Chiba
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Mexico
State/province [44] 0 0
Nuevo Leon
Country [45] 0 0
Mexico
State/province [45] 0 0
Mexico D.F.
Country [46] 0 0
Mexico
State/province [46] 0 0
Querétaro
Country [47] 0 0
Poland
State/province [47] 0 0
Krakow
Country [48] 0 0
Poland
State/province [48] 0 0
Otwock
Country [49] 0 0
Portugal
State/province [49] 0 0
Coimbra
Country [50] 0 0
Portugal
State/province [50] 0 0
Lisboa
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Novosibirsk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St. Petersburg
Country [53] 0 0
Slovakia
State/province [53] 0 0
Bratislava 37
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Switzerland
State/province [55] 0 0
Zürich
Country [56] 0 0
Taiwan
State/province [56] 0 0
Taipei
Country [57] 0 0
Turkey
State/province [57] 0 0
Ankara
Country [58] 0 0
Turkey
State/province [58] 0 0
Istanbul
Country [59] 0 0
Turkey
State/province [59] 0 0
Izmir
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cambridgeshire
Country [61] 0 0
United Kingdom
State/province [61] 0 0
West Dunbartonshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00910429
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries