Overview

Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients

Status:
Unknown status
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
LG Life Sciences
Treatments:
Amlodipine
Valsartan
Criteria
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