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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
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
Not applicable
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00910429