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.
Study Type
OBSERVATIONAL
Enrollment
2,001
LG Life Science
Seoul, Jongno gu, South Korea
RECRUITINGSafety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
Time frame: 6month
mean change of the blood pressure and pulse after administation of drug at 12week and 24week.
Time frame: 12weeks, 24weeks
BP control rate
Time frame: 12weeks, 24weeks
Responder rate
Time frame: 12weeks, 24weeks
Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available
Time frame: 12weeks, 24weeks
Evaluation of cardiovascular risk
Time frame: 12weeks, 24weeks
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