Lower Leg Edema, Orthostatic Hypertension
Conditions
Keywords
safety data, hypertension therapy
Brief summary
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.
Interventions
DRUGLevacalm
Sponsors
LG Life Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. those who can't maintain the blood pressure with the antihypertensive drug before. 2. those who diagnosed to a hypertension stage 2.(DBP is higher than 160mmHg or SBP is higher than 100mmHg) 3. 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.
Exclusion criteria
1. Those who are included in the contraindication of study drug following the information for use of the product 2. Those who is/will be participated in other drug clinical trial 3. Those who adminitrated other antihypertensive drugs beside the levacalm or Valsartan/amlodipine combination drug. 4. Those who judged by the invesigator as ineligible for this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire. | 6month |
Secondary
| Measure | Time frame |
|---|---|
| mean change of the blood pressure and pulse after administation of drug at 12week and 24week. | 12weeks, 24weeks |
| BP control rate | 12weeks, 24weeks |
| Responder rate | 12weeks, 24weeks |
| Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available | 12weeks, 24weeks |
| Evaluation of cardiovascular risk | 12weeks, 24weeks |
Countries
South Korea
Contacts
Primary ContactHye Jin Yoon
Outcome results
None listed