NCT00940628已完成3 期
Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in BMI
研究概览
简要总结
This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adolescent patients, 12-14 years of age
- •overweight or obese
排除标准
- •age <12 or >14 years
- •BMI in normal range
研究组 & 干预措施
1
Experimental
干预措施: Diet and Exercise (Behavioral)
1
Experimental
干预措施: orlistat [Xenical] (Drug)
2
Other
干预措施: Diet and Exercise (Behavioral)
结局指标
主要结局
Change in BMI
时间窗: At each clinic visit, every 4 weeks
次要结局
- Adverse events, laboratory parameters(At each clinic visit, every 4 weeks)
研究者
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