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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00863681




Registration number
NCT00863681
Ethics application status
Date submitted
13/03/2009
Date registered
18/03/2009
Date last updated
7/11/2023

Titles & IDs
Public title
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Scientific title
Long-term Extension, Multicentre, Multi-national 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 Symptomatic Pulmonary Arterial Hypertension (PAH)
Secondary ID [1] 0 0
2008-003610-94
Secondary ID [2] 0 0
12935
Universal Trial Number (UTN)
Trial acronym
PATENT-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 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 (BAY63-2521)

Experimental: Arm 1 -


Treatment: Drugs: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid -2.5 mg tid oral 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 in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.
Primary outcome [2] 0 0
Number of Participant With Death
Timepoint [2] 0 0
From baseline to end of safety follow-up visit, up to 10 years and 6 months (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
Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
Timepoint [3] 0 0
From baseline to termination visit, up to 10 years
Secondary outcome [4] 0 0
Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
Timepoint [4] 0 0
From baseline to termination visit, up to 10 years

Eligibility
Key inclusion criteria
* Patients who have completed 12 weeks of treatment in the double blind trial PATENT 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 PATENT 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
12/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2019
Sample size
Target
Accrual to date
Final
396
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Auchenflower
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
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
Capital Federal
Country [8] 0 0
Austria
State/province [8] 0 0
Oberösterreich
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Austria
State/province [10] 0 0
Wien
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles - Brussel
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio Grande Do Sul
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio de Janeiro
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 2
Country [22] 0 0
Denmark
State/province [22] 0 0
Aarhus N
Country [23] 0 0
France
State/province [23] 0 0
Besancon
Country [24] 0 0
France
State/province [24] 0 0
Brest
Country [25] 0 0
France
State/province [25] 0 0
GRENOBLE Cedex 09
Country [26] 0 0
France
State/province [26] 0 0
Lille Cedex
Country [27] 0 0
France
State/province [27] 0 0
Montpellier
Country [28] 0 0
France
State/province [28] 0 0
Pessac
Country [29] 0 0
France
State/province [29] 0 0
Rouen
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Württemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
Germany
State/province [32] 0 0
Hessen
Country [33] 0 0
Germany
State/province [33] 0 0
Mecklenburg-Vorpommern
Country [34] 0 0
Germany
State/province [34] 0 0
Niedersachsen
Country [35] 0 0
Germany
State/province [35] 0 0
Nordrhein-Westfalen
Country [36] 0 0
Germany
State/province [36] 0 0
Saarland
Country [37] 0 0
Germany
State/province [37] 0 0
Sachsen
Country [38] 0 0
Greece
State/province [38] 0 0
Chaidari
Country [39] 0 0
Italy
State/province [39] 0 0
Friuli-Venezia Giulia
Country [40] 0 0
Italy
State/province [40] 0 0
Lazio
Country [41] 0 0
Italy
State/province [41] 0 0
Lombardia
Country [42] 0 0
Japan
State/province [42] 0 0
Aichi
Country [43] 0 0
Japan
State/province [43] 0 0
Hyogo
Country [44] 0 0
Japan
State/province [44] 0 0
Ibaraki
Country [45] 0 0
Japan
State/province [45] 0 0
Ishikawa
Country [46] 0 0
Japan
State/province [46] 0 0
Miyagi
Country [47] 0 0
Japan
State/province [47] 0 0
Okinawa
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Japan
State/province [49] 0 0
Hiroshima
Country [50] 0 0
Japan
State/province [50] 0 0
Okayama
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Mexico
State/province [52] 0 0
Jalisco
Country [53] 0 0
Mexico
State/province [53] 0 0
Nuevo Leon
Country [54] 0 0
Mexico
State/province [54] 0 0
Sinaloa
Country [55] 0 0
Mexico
State/province [55] 0 0
Mexico D.F.
Country [56] 0 0
Mexico
State/province [56] 0 0
Querétaro
Country [57] 0 0
Poland
State/province [57] 0 0
Otwock
Country [58] 0 0
Portugal
State/province [58] 0 0
Coimbra
Country [59] 0 0
Portugal
State/province [59] 0 0
Lisboa
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
St. Petersburg
Country [62] 0 0
Singapore
State/province [62] 0 0
Singapore
Country [63] 0 0
Sweden
State/province [63] 0 0
Umeå
Country [64] 0 0
Switzerland
State/province [64] 0 0
Zürich
Country [65] 0 0
Taiwan
State/province [65] 0 0
Kaohsiung City
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei
Country [67] 0 0
Thailand
State/province [67] 0 0
Bangkok
Country [68] 0 0
Thailand
State/province [68] 0 0
Chiang Mai
Country [69] 0 0
Turkey
State/province [69] 0 0
Ankara
Country [70] 0 0
Turkey
State/province [70] 0 0
Istanbul
Country [71] 0 0
Turkey
State/province [71] 0 0
Izmir
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Cambridgeshire
Country [73] 0 0
United Kingdom
State/province [73] 0 0
West Dunbartonshire
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London

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?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00863681