An Observational Study to Identify BEnefits After 24 Weeks of NEBILET®(Nebivolol) Administration For Essential hypertensIon Patients With Various Co-morbidities and Treatment Environments in KOREA.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,250
- 试验地点
- 1
- 主要终点
- Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure
研究概览
简要总结
The purpose of this study is:
To evaluate the effects of NEBILET®(Nebivolol), used as monotherapy or in combination with other antihypertensive agents, in the control of BP and in the metabolic profile of patients with essential hypertension (with or without co-morbidities) after 12 weeks and 24 weeks.
详细描述
Nebivolol, the third-generation beta-blocker with vasodilatory effect, potentiates nitric oxide by activating the synthesis of nitric oxide of vascular endothelial cells and improves the function of vascular endothelial cells by reducing oxidation stress. The efficacy of NEBILET®(Nebivolol) has been demonstrated in randomized controlled trials not only as monotherapy but also as add-on therapy with angiotensin-converting-enzyme inhibitor, angiotensin II receptor blocker, diuretic and other anti-hypertensive agents in lowering the blood pressure.
Based on previous study results mentioned above, the present study aims to observe the effect of NEBILET®(Nebivolol) on controlling blood pressure and metabolic profile change in Korean patients with hypertension under routine clinical practice.
In addition, this study aims to identify additional benefits of NEBILET®(Nebivolol) administration in patients with essential hypertension under various treatment environments and existing co-morbidities in Korea, expected to provide detailed information about efficacy of blood pressure control, lipid and carbohydrate metabolism of NEBILET®(Nebivolol) administration in Korean patients with essential hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Male and female patient aged 19 and older
- •In patient diagnosed with essential hypertension,
- •Patients who can be first treated with NEBILET®(Nebivolol) to lower high blood pressure
- •In patients who are receiving other antihypertensive medications, those who can switch one of the antihypertensive agents to NEBILET®(Nebivolol) or use NEBILET®(Nebivolol) as an additional therapy (In case where one of other antihypertensive agents is switched to NEBILET®(Nebivolol), it is imperative that the dose of the previous medication should exhibit the same antihypertensive effect as NEBILET®(Nebivolol) 5 mg.)
- •Subjects who have signed the written informed consent form for their voluntary participation
排除标准
- •Patient with hypersensitivity to the NEBILET®(Nebivolol) substance
- •Patient with history of bronchospasm
- •Patient with history of bronchial asthma
- •Patient with metabolic acidosis
- •Patient with bradycardia(heart rate< 60 bpm)
- •Patient with second and third degree atrioventricular block
- •Patient with acute heart failure, cardiogenic shock, or episodes of heart failure decompensation requiring i.v. inotropic therapy)
- •Patient with uncontrolled severe heart failure
- •Patient with hypotension (Systolic Blood Pressure < 90mmHg)
- •Patient with severe peripheral circulatory disturbances
- •Patient with sick sinus syndrome including sino-atrial block
- •Patient with untreated pheochromocytoma
- •Patient with hepatic insufficiency
- •Patient with impaired liver function
- •Pregnant woman
- •Nursing mother
- •Patient with chronic heart failure who has severe renal insufficiency (serum creatinine ≥ 250 micro mol/L)
- •Patient with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption
- •Patient who has participated in other clinical trial within the last 3 months
结局指标
主要结局
Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure
时间窗: 24 weeks
Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure after 12 weeks(±2 weeks) and 24 weeks (±2 weeks) compared to Baseline
次要结局
- Mean change of the Systolic Blood Pressure and Diastolic Blood Pressure compared to baseline depending on the treatment status and type of anti-hypertensive concomitant medication(24 weeks)
- Controlled patient rate in targeted Systolic Blood Pressure and Diastolic Blood Pressure range(24 weeks)
- Change of glucose (HbA1c, fasting blood sugar), Na, K, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol(24 weeks)
- Changes in Heart Rate and Heart Rate Variability after treatment with NEBILET® (Nebivolol) versus baseline values in patients receiving the concomitant antihypertensive therapies.(24 weeks)