NCT01872182终止3 期
A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年5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
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percent change from baseline to 12 week in visceral fat area measured by CT
研究概览
简要总结
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 and 64 years(Both genders)
- •more than 2 among components of the metabolic syndrome
- •Triglyceride >= 150mg/dL
- •HDL-D: Women < 50mg/dL or Men < 40mg/dL
- •Hypertension: Systolic blood pressure >= 130mmHg or Diastolic blood pressure >= 85mmHg
- •Hyperglycemia: fasting plasma glucose >= 100 mg/dL
- •Informed consent awarding
排除标准
- •Alcohol or any drug abuse
- •Any investigational medication during the preceding 3 months
研究组 & 干预措施
Test arm
Experimental
ALS-L1023 300mg in two tablets
干预措施: ALS-L1023 (Drug)
Comparator arm
Placebo Comparator
placebo in two tablets
干预措施: placebo (Drug)
结局指标
主要结局
Percent change from baseline to 12 week in visceral fat area measured by CT
时间窗: baseline and 12 week
次要结局
- change of BMI(baseline and 12 week)
- improvement of metabolic profile(baseline and 12 week)
- change of insulin resistance(baseline and 12 week)
研究者
研究点 (1)
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