Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02232061
• Date of registration: 02/09/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod
• Scientific title: Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod
• Date of first enrolment: September 29, 2014
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02232061
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, Germany, Italy

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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:

-



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Fingolimod

Primary Outcome(s)

Incidence rate of selected cardiovascular serious adverse events (SAE) [Time Frame: 72 month]

Secondary ID(s)

CFTY720D2409

Source(s) of Monetary Support

Please refer to primary and secondary sponsors