NCT01397240Unknown4 期
The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients Taking Low-dose Aspirin, A Pilot Study
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence rate of Gastric Ulcer
研究概览
简要总结
The purpose of this study is to research the safety and efficacy of Albis® for the prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.
详细描述
The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients taking Low-dose Aspirin, A pilot study Double-Blind, Placebo-Controlled, Randomized, Multicenter, Parallel, Prospective study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 20 to 80 years
- •Subjects identified with at least one of the following diagnosis (Angina, Myocardial Infarction(Old), Cerebrovascular Disease, Peripheral Vascular Disease, Diabetes, Hypertension, Hypercholeseterolemia, Obesity) who are required to take a low dose of Aspirin (100mg/day) for more than 12 weeks.
排除标准
- •Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
- •Peptic ulcer or Reflux oesophagitis
- •hemostatic disorder or coagulation disorder
- •Known allergy or hypersensitivity to the study medication
研究组 & 干预措施
Albis
Experimental
Drug: Albis Tab 2 tab, twice a day
干预措施: Albis Tab (Drug)
Placebo
Placebo Comparator
Placebo 2 tab, twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence rate of Gastric Ulcer
时间窗: 2 years
次要结局
- Incidence rate of gastiritis(2 years)
研究者
研究点 (1)
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