Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity (TOLERASIT)

February 26, 2025 updated by: Eurofarma Laboratorios S.A.

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 06696-000
        • Eurofarma Laboratórios S.A
    • SP
      • São Paulo, SP, Brazil
        • HC-FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, with prescribed treatment between the year 2011 and the beginning of the study

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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