Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,794
- 主要终点
- A primary endpoint is the incidence of adverse events.
研究概览
简要总结
This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
详细描述
The population will be selected from 200 institutions in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.
- •Zetia monotherapy patients must be treated with Zetia alone.
- •Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.
排除标准
- •Patients with a history of hypersensitivity to any ingredient in Zetia
- •Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.
研究组 & 干预措施
Zetia monotherapy
Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia
干预措施: Ezetimibe (Drug)
Zetia combination therapy
Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia
干预措施: Ezetimibe + other lipid-lowering medication(s) (Drug)
结局指标
主要结局
A primary endpoint is the incidence of adverse events.
时间窗: Adverse events will be monitored throughout the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
A primary endpoint is change in LDL-C
时间窗: LDL-C at start of 52 weeks will be compared to LDL-C at the end of the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
次要结局
未报告次要终点