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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 February 2024 |
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Main ID: |
NCT02428985 |
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Date of registration:
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21/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)
JPMS-PAH |
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Scientific title:
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Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH) |
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Date of first enrolment:
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June 29, 2015 |
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Target sample size:
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882 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02428985 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who are treated with Riociguat for PAH
Exclusion Criteria:
- N/A
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Drug: Riociguat (ADEMPAS, BAY63-2521)
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Primary Outcome(s)
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Number of participants with treatment emergent adverse events. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema
[Time Frame: Up to 7 years]
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Number of participants with adverse drug reaction
[Time Frame: Up to 7 years]
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Secondary Outcome(s)
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Change from baseline in 6-Minute Walking Distance at 3 months and 12 months
[Time Frame: Baseline and 3 months,Baseline and 12 months]
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Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months
[Time Frame: Baseline and 3 months,Baseline and 12 months]
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Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months
[Time Frame: Baseline and 3 months,Baseline and 12 months]
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Change from baseline in WHO functional class after 3 and 12 months
[Time Frame: Baseline and 3 months,Baseline and 12 months]
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Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months.
[Time Frame: Baseline and 3 months,Baseline and 12 months]
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Time to Clinical Worsening
[Time Frame: Up to 7 years]
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Secondary ID(s)
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17519
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AD1510JP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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