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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00863681
Ethics application status
Date submitted
13/03/2009
Date registered
18/03/2009
Date last updated
22/10/2020

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) - Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
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 - 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.
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 - Percentage 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. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after 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.
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 - Percentage 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. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after 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.
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 - Percentage 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. The percentage was calculated by comparing the number of participants with a normal or low value at baseline who had at least one high value after the start of treatment with the number of participants with a normal or low value at baseline who also had at least one valid value after 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.
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 - Percentage 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. The percentage was calculated by comparing the number of participants with a normal or high value at baseline who had at least one low value after the start of treatment with the number of participants with a normal or high value at baseline who also had at least one valid value after 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.
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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
- Chermside
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
4032 - Chermside
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
Kaoshiung
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
Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934)
will be asked to participate in this long term extension study with BAY63-2521.
Trial website
https://clinicaltrials.gov/show/NCT00863681
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

Summary results
Other publications