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

NCT ID: NCT05209997

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Source 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurofarma Laboratórios S.A

São Paulo, São Paulo, Brazil

Site Status

HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EF179

Identifier Type: -

Identifier Source: org_study_id

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