A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,001
- 试验地点
- 1
- 主要终点
- Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
研究概览
简要总结
Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus, there's no enough safety data and efficacy data defined from the clinical study.
Also, many combination drugs of valsartaa and amlodipine are widely used in the market.
LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this study.
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
- 否
入选标准
- •patients aged over 19 with essential hypertension
- •Those who meet the inclusion criteria, fall under any of the following 3 cases and determined by the investigator to be prescribed Levacalm or Valsartan/Amlodipine combination:
- •those who can't maintain the blood pressure with the antihypertensive drug before.
- •those who diagnosed to a hypertension stage 2.(DBP is higher than 160mmHg or SBP is higher than 100mmHg)
- •those who fall under the following :cardiovascular disease, Cerebrovascular disease, chronic Renal disease, diabetes mellitus, peripheral vascular disease
- •Those who were informed of the purpose, method, and effect etc. of this study and signed the informed consent form.
排除标准
- •Those who are included in the contraindication of study drug following the information for use of the product
- •Those who is/will be participated in other drug clinical trial
- •Those who adminitrated other antihypertensive drugs beside the levacalm or Valsartan/amlodipine combination drug.
- •Those who judged by the invesigator as ineligible for this clinical study
研究组 & 干预措施
Patients treated with Levacalm
In this group, the patients will be enrolled treated with Levacalm tab. as an anti-hypertensive drug.
The number of this group will be double than the control group to get more information about safety and efficacy.
干预措施: Levacalm (Drug)
Patients treated with Valsartan/amlodipine
In this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug.
干预措施: Valsartan/amlodipine (Drug)
结局指标
主要结局
Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
时间窗: 6month
次要结局
- mean change of the blood pressure and pulse after administation of drug at 12week and 24week.(12weeks, 24weeks)
- Responder rate(12weeks, 24weeks)
- Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available(12weeks, 24weeks)
- BP control rate(12weeks, 24weeks)
- Evaluation of cardiovascular risk(12weeks, 24weeks)