ong-term, multicenter study assessing long-term heart risks in patients treated with fingolimod

Phase 1

• Conditions: Cardiovascular risk; MedDRA version: 17.0Level: PTClassification code 10053046Term: Cardiovascular evaluationSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001241-24-IT
• Lead Sponsor: ovartis Farma SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-14
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed
2. Patient experienced a cardiovascular event within 24-hours of fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria
3. Patient experienced this cardiovascular event while participating in the study CFTY720D2406
4. Patient continues receiving fingolimod after the first dose event
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified