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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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16 December 2017 |
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Main ID: |
NCT02826252 |
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Date of registration:
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05/07/2016 |
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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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Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20)
VENTASWITCH |
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Scientific title:
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VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20) |
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Date of first enrolment:
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September 15, 2016 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02826252 |
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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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N/A
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Countries of recruitment
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Germany
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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 aged =18 years at time of signing informed consent.
- Patients, diagnosed with group 1 PAH.
- Patients must be enrolled in the German Ventavis patient support program Ventaplus.
- Patients who either already switched from V10 to V20 therapy or who agreed to do so
according to their physician's decision.
- Patients must have been on V10 therapy for at least 2 weeks.
- Written informed consent must be obtained.
Exclusion Criteria:
- participation in other clinical or interventional study.
Age minimum:
18 Years
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: Iloprost,(Ventavis, BAYQ6256)
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Device: I-Neb AAD system
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Primary Outcome(s)
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Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
[Time Frame: Up to 6 months]
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Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL
[Time Frame: Up to 6 months]
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Secondary Outcome(s)
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Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL
[Time Frame: Up to 6 months]
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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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