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

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.

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05209997
Acronym
TOLERASIT
Enrollment
0
Registered
2022-01-27
Start date
2024-12-01
Completion date
2025-12-01
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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.

Interventions

OTHERSource document data collection

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.

Sponsors

Eurofarma Laboratorios S.A.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The percentage of patients who achieved a weight loss greater than 5%20 yearsIdentification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026