Status:
COMPLETED
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events
Detailed Description
This was a multi-national, long-term safety study. Patients enrolled in study FTY720D2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation which led to overnig...
Eligibility Criteria
Inclusion
- Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.
- Patients still on fingolimod after the this first dose serious event
Exclusion
- Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month
Key Trial Info
Start Date :
September 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02232061
Start Date
September 29 2014
End Date
January 24 2020
Last Update
February 10 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Ghent, Belgium, 9000
2
Novartis Investigative Site
Hasselt, Belgium, 3500
3
Novartis Investigative Site
Ravensburg, Germany, 88212
4
Novartis Investigative Site
Napoli, Italy, 80131