NCT05209997撤回不适用
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 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- The percentage of patients who achieved a weight loss greater than 5%
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
- •Individual use of one of the medications (sibutramine or topiramate)
结局指标
主要结局
The percentage of patients who achieved a weight loss greater than 5%
时间窗: 20 years
Identification of the percentage of patients who achieved a weight loss greater than 5% in relation to the initial body weight.
次要结局
未报告次要终点
研究者
研究点 (2)
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