Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks

• Status: Completed
• Trial end date: 2020-01-24
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month