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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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6 November 2023 |
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Main ID: |
NCT02825160 |
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Date of registration:
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15/06/2016 |
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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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Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)
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Scientific title:
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Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH) |
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Date of first enrolment:
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August 1, 2016 |
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Target sample size:
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295 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02825160 |
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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 diagnosed with PAH
- Patients for whom the decision to initiate treatment with Ventavis was made as per
investigator's routine treatment practice.
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: Ventavis (Iloprost, BAYQ6256)
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Primary Outcome(s)
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Number of participants with adverse drug reaction
[Time Frame: Up to 5 years]
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Number of participants with treatment emergent adverse events (TEAE) of special interest.
[Time Frame: Up to 5 years]
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Secondary Outcome(s)
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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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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 6-Minute Walking Distance 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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Time to Clinical Worsening
[Time Frame: Up to 5 years]
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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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