NCT03063697Unknown不适用
Prospective, Multi-center, Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20,000
- 主要终点
- The incidence and severity of adverse events and adverse drug reactions at 24 weeks
研究概览
简要总结
The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 years or older Patients with Essential hypertension, Chronic stable angina and Congestive heart failure
- •Possible to take Dilatrend SR on the label
- •not taking Caverdilol for 6 month from Agreement date
- •Agreement with written informed consent
排除标准
- •Pregnancy or lactation
- •Known hypersensitivity to Carvedilol
- •Cardiogenic shock
- •Abnormality of the conduction system as Severe bradycardia(In particular, pulse <50beats / min), 2nd degree AV block, Complete AV block, Sinus Block, Sick Sinus Syndrome
- •Cor pulmonale
- •IDDM with ketoacidosis, metabolic acidosis
- •has severe heart disease(Heart failure NYHA functional class 4)
- •Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease
- •Secondary hypertension
- •Prinzmetal's angina
- •Acute pulmonary embolism
- •Pheochromocytoma
- •Take MAO lnhibitor(except for MAO-B)
- •Hypotension ( SBP 90mmHg or less)
- •Severe hepatic dysfunction
- •Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
- •Has edema glottitis
- •Has heart attack with complication
- •Fluid retention or overload to required intravenous inotropes
- •Allergic rhinitis
结局指标
主要结局
The incidence and severity of adverse events and adverse drug reactions at 24 weeks
时间窗: for 24 weeks
The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks
时间窗: for 24 weeks
次要结局
未报告次要终点
研究者
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