MedTrace Logo

Study of the Effect of the Benfluorex

NCT02008552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2021-12-21

No results posted yet for this study

Summary

More than 5 million persons in France exposed, in last years, to the taking of the Benfluorex.

Arisen, at certain patients, of a valvulopathy characterized by mitrals and/or aortic leaks Withdrawal of the French market: nov. 2009 Only a percentage limited by exposed patients developed a severe valvulopathy (1/1000), whereas on the contrary, many patients were exposed during years without developing the slightest anomaly.

The hypothesis is the existence of a particular genetic susceptibility at the patients having developed a valvulopathy continuation in the exposure in this medicine.

Existence of one varying genetics with strong effect. The purpose is to identify involved genetic factors.

Conditions

  • Blood Sample

Interventions

GENETIC

Sampling of blood

Sampling of blood was taken and analyse to research factor genetic

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Irène Frachon, PH · CHRU de Brest

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-18
Primary Completion
2021-10-18
Completion
2021-10-18

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02008552 on ClinicalTrials.gov