NCT00234988已完成4 期
Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has nutritional obesity and BMI >30 kg/m
排除标准
- •Type 1 or type 2 diabetes mellitus
- •Inadequately controlled hypertension
- •History of Gilles de la Tourette's Syndrome.
- •Use of any MAOIs, SSRIs, amino acids, antimigraine drugs, opioids
- •Hypothyroidism or hyperthyroidism.
- •History of:
- •benign prostatic hyperplasia
- •neurological disorders
- •psychiatric illness
- •severe renal or hepatic impairments
- •narrow-angle glaucoma
- •History of cardiovascular disease or cerebrovascular disease
- •Persistent tachycardia at rest
- •Pulmonary hypertension
- •Phaeochromocytoma
研究组 & 干预措施
1
Experimental
干预措施: sibutramine hydochloride monohydrate (Drug)
结局指标
主要结局
Weight loss
时间窗: 48 weeks
Safety parameters
时间窗: 48 weeks
次要结局
- Waist and hip circumference(48 weeks)
- Fasting glucose(48 weeks)
- Fasting lipids(48 weeks)
- Uric acid(48 weeks)
研究者
研究点 (1)
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