Skip to main content
Clinical Trials/NCT05209997
NCT05209997
Withdrawn
Not Applicable

An Observational, Multicenter, National Study with Real-life Retrospective Data Collection on the Combined Use of Sibutramine and Topiramate As Anti-obesity Treatment in Overweight Patients with Comorbidity(ies) or Obesity.

Eurofarma Laboratorios S.A.2 sites in 1 country1,500 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
Eurofarma Laboratorios S.A.
Enrollment
1500
Locations
2
Primary Endpoint
The percentage of patients who achieved a weight loss greater than 5%
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
December 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Eurofarma Laboratorios S.A.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients
  • Both sexes
  • Diagnose of overweight with comorbidity(ies) or obesity
  • Treatment use of sibutramine combined with topiramate
  • Treatment prescription between 2011 and the beginning of the study

Exclusion Criteria

  • Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
  • Individual use of one of the medications (sibutramine or topiramate)

Outcomes

Primary Outcomes

The percentage of patients who achieved a weight loss greater than 5%

Time Frame: 20 years

Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.

Study Sites (2)

Loading locations...

Similar Trials