Study Stopped
The study was withdrawn following a thorough evaluation of the current scientific landscape and ongoing advancements in the field. This decision was made to ensure that the research remains aligned with the highest standards of innova
Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity
TOLERASIT
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.
1 other identifier
observational
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2024
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 28, 2025
February 1, 2025
4 months
January 14, 2022
February 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage of patients who achieved a weight loss greater than 5%
Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.
20 years
Interventions
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 colected in the study.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
- Individual use of one of the medications (sibutramine or topiramate)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eurofarma Laboratórios S.A
São Paulo, São Paulo, 06696-000, Brazil
HC-FMUSP
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
December 1, 2024
Primary Completion
April 1, 2025
Study Completion
December 1, 2025
Last Updated
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share