NCT01755676已完成3 期
A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults
EMS5 个研究点 分布在 1 个国家目标入组 638 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 638
- 试验地点
- 5
- 主要终点
- Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
研究概览
简要总结
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent;
- •Adults Male and Female ≥ 18 years old;
- •Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);
排除标准
- •Pregnancy and Lactation or women without effective contraception;
- •Relevant clinical diseases;
- •Obesity associated to genetic syndrome;
- •Decompensated Diabetes;
- •Psychiatric disorders;
- •Alimentary disorders;
- •Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days;
- •Patients using cyclosporine or amiodarone;
- •Patients with bowel disease;
- •Prior bariatric surgery;
- •Hemoglobinopathies and coagulopathy;
- •History of cancer in the past five years;
- •Use of corticosteroids, oral or injectable, in the last 30 days.
研究组 & 干预措施
Orlistat 60 mg
Experimental
干预措施: Orlistat 60 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
时间窗: 112 days
次要结局
- Safety will be evaluated by the adverse events occurrences(112 days)
研究者
研究点 (5)
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