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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02232061 |
Date of registration:
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02/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod
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Scientific title:
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Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod |
Date of first enrolment:
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September 29, 2014 |
Target sample size:
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6 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02232061 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Germany
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Italy
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Contacts
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Name:
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Novartis Pharmaceuticals |
Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients participating in study FTY720D2406 who experienced a serious cardiovascular
event during their fingolimod treatment initiation
- Patients still on fingolimod after the this first dose serious event
Exclusion Criteria:
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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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Multiple Sclerosis
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Intervention(s)
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Drug: Fingolimod
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Primary Outcome(s)
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Incidence rate of selected cardiovascular serious adverse events (SAE)
[Time Frame: 72 month]
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Secondary ID(s)
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CFTY720D2409
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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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