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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/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
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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)
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Secondary ID [1]
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2008-003610-94
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Secondary ID [2]
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12935
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Universal Trial Number (UTN)
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Trial acronym
PATENT-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAE)
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Assessment method [1]
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Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
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Timepoint [1]
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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.
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Primary outcome [2]
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Number of Participant With Death
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Assessment method [2]
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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.
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Timepoint [2]
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From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit)
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Secondary outcome [1]
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Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation
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Assessment method [1]
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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.
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Timepoint [1]
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From baseline to termination visit, up to 10 years
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Secondary outcome [2]
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Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation
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Assessment method [2]
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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.
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Timepoint [2]
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From baseline to termination visit, up to 10 years
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Secondary outcome [3]
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Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry
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Assessment method [3]
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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.
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Timepoint [3]
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From baseline to termination visit, up to 10 years
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Secondary outcome [4]
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Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry
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Assessment method [4]
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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.
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Timepoint [4]
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From baseline to termination visit, up to 10 years
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Eligibility
Key inclusion criteria
- Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/03/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/08/2019
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Sample size
Target
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Accrual to date
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Final
396
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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- Darlinghurst
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Recruitment hospital [2]
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- Auchenflower
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Recruitment hospital [3]
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- Herston
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Recruitment hospital [4]
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- Hobart
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Recruitment hospital [5]
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- Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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7000 - Hobart
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Recruitment postcode(s) [5]
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3181 - Prahran
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Massachusetts
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United States of America
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Nebraska
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United States of America
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Ohio
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Texas
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Argentina
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Capital Federal
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Austria
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Oberösterreich
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Bruxelles - Brussel
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Belgium
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Leuven
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Canada
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Quebec
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Guangdong
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China
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Beijing
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China
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Shanghai
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Czechia
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Praha 2
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Denmark
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Aarhus N
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Besancon
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France
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Brest
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France
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GRENOBLE Cedex 09
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France
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Lille Cedex
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France
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France
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Pessac
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France
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Rouen
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Saarland
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Germany
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Sachsen
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Greece
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Chaidari
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Aichi
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Hyogo
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Ibaraki
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Japan
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Ishikawa
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Japan
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Miyagi
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Japan
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Okinawa
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Tokyo
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Japan
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Hiroshima
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Japan
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Okayama
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Korea, Republic of
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Seoul
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Jalisco
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Mexico
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Mexico
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Querétaro
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Poland
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Otwock
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Portugal
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Coimbra
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Portugal
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Lisboa
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Singapore
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Sweden
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Umeå
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Switzerland
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Zürich
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Taiwan
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Kaohsiung City
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Cambridgeshire
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United Kingdom
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West Dunbartonshire
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00863681
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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.
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Contact person for public queries
Name
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00863681
Download to PDF