NCT02385721已完成不适用
A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing AEs or ADRs
研究概览
简要总结
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
详细描述
This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension
- •Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly
- •Male and female adults aged 20 years or older
- •Voluntarily provided a written consent to participate in the study
排除标准
- •Patients with hypersensitivity to this drug or the ingredients of this drug
- •Pregnant or breast-feeding women
- •Patients on renal dialysis
- •Patients with moderate to severe hepatic impairment
- •Patients with biliary atresia
- •Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
- •Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator
- •Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)
结局指标
主要结局
Number of Participants Experiencing AEs or ADRs
时间窗: up to 12 months
Number of participants experiencing AEs (or ADRs) during the study
次要结局
- Treatment Persistence Rate of Fimasartan(up to 12 months)
研究者
研究点 (1)
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