NCT00909389已完成不适用
Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,748
- 主要终点
- Number of Participants Who Had an Adverse Event (AE).
研究概览
简要总结
This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient men or women, age 18 years and above
- •Patients with primary (heterozygous familial and non-familial) hypercholesterolemia
排除标准
- •Known hypersensitivity to Ezetimibe and Simvastatin
- •Moderate to severe hepatic insufficiency
- •Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal
- •Pregnancy or lactation
- •Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
研究组 & 干预措施
Filipino Patients with Hypercholesterolemia
干预措施: Vytorin (R) (Ezetimibe + Simvastatin) (Drug)
结局指标
主要结局
Number of Participants Who Had an Adverse Event (AE).
时间窗: Throughout study up to Day 29 (Final Visit)
The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.
次要结局
未报告次要终点
研究者
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