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

• Conditions: Lower Leg Edema; Orthostatic Hypertension
• Interventions: Drug: Levacalm; Drug: Valsartan/amlodipine

• Registration Number: NCT02415192
• Lead Sponsor: LG Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-14
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19
• Primary Completion: 2016-10
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2001

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with Levacalm	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	Valsartan/amlodipine	In this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
mean change of the blood pressure and pulse after administation of drug at 12week and 24week.	12weeks, 24weeks
Responder rate	12weeks, 24weeks
Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available	12weeks, 24weeks
BP control rate	12weeks, 24weeks
Evaluation of cardiovascular risk	12weeks, 24weeks

Trial Locations

Locations (1)

LG Life Science; 🇰🇷 Seoul, Jongno gu, Korea, Republic of