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

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ClinicalTrials.gov Identifier: NCT02232061
Recruitment Status : Recruiting
First Posted : September 4, 2014
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Fingolimod Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod
Actual Study Start Date : September 29, 2014
Estimated Primary Completion Date : July 6, 2020
Estimated Study Completion Date : July 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fingolimod Drug: Fingolimod



Primary Outcome Measures :
  1. Incidence rate of selected cardiovascular serious adverse events (SAE) [ Time Frame: 72 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232061


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Belgium
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
Novartis Investigative Site Recruiting
Hasselt, Belgium, 3500
Novartis Investigative Site Withdrawn
Verviers, Belgium, 4800
Germany
Novartis Investigative Site Recruiting
Ravensburg, Germany, 88212
Novartis Investigative Site Recruiting
Trier, Germany, 54292
Italy
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02232061     History of Changes
Other Study ID Numbers: CFTY720D2409
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
multiple sclerosis, fingolimod,
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs