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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2001 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Lower Leg Edema Orthostatic Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Levacalm

Intervention Type 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.

Valsartan/amlodipine

Intervention Type DRUG

Interventions

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Levacalm

Intervention Type DRUG

Valsartan/amlodipine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients aged over 19 with essential hypertension

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No