FOLLOW UP study for patients previously included in REGULATE study.

Phase 3

Completed

Registration Number: CTRI/2011/11/002144

Lead Sponsor: Institut de recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 845

Inclusion Criteria

All the patients exposed to one of the study drugs during the REGULATE trial who agree to participate in the follow-up study or who give written authorisation to the investigator for the medical data collection despite their incapacity to visit the investigating site will be included.

Exclusion Criteria

Not applicable

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International follow-up study without a study treatment administration; safety profiles in both treatment groups from REGULATE trial (benfluorex Vs Pioglitazone) will be assessed. <br/ ><br> <br/ ><br>The main assessment criteria will be the emergence of valvular abnormalities between REGULATE baseline and follow-up visit. For this, the central readers will follow the recommendations described by the American Society of echocardiography report in grading regurgitation severity. <br/ ><br>Timepoint: International follow-up study without a study treatment administration; safety profiles in both treatment groups from REGULATE trial (benfluorex Vs Pioglitazone) will be assessed. <br/ ><br> <br/ ><br>The main assessment criteria will be the emergence of valvular abnormalities between REGULATE baseline and follow-up visit. For this, the central readers will follow the recommendations described by the American Society of echocardiography report in grading regurgitation severity. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
<br/ ><br>-The evolution of valvular abnormalities since the end of REGULATE trial, <br/ ><br>-Other transthoracic echocardiography findings including pulmonary hypertension since the end of REGULATE trial, <br/ ><br>-Medical events including hospitalizations since the end of REGULATE trial, <br/ ><br>-Mortality rate since the start of REGULATE trial. <br/ ><br>Timepoint: 0 week and 6 weeks