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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Patients treated with Valsartan/amlodipine | In this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levacalm | Drug |
| ||
| Valsartan/amlodipine |
| Measure | Description | 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 |
| Measure | Description | 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 |
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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:
Those who were informed of the purpose, method, and effect etc. of this study and signed the informed consent form.
Exclusion Criteria:
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Patients with essential hypertension
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye Jin Yoon | Contact | 82-2-6924-3148 | hyejin0611@lgls.com |
| Name | Affiliation | Role |
|---|---|---|
| Keun Soo Bang | LG Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG Life Science | Recruiting | Seoul | Jongno gu | 110-783 | South Korea |
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|
| 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 |
| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017311 | Amlodipine |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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