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

April 18, 2016 updated by: LG Life Sciences

A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno gu
      • Seoul, Jongno gu, Korea, Republic of, 110-783
        • Recruiting
        • LG Life Science
        • Contact:
          • Hye jin Yoon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with essential hypertension

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 6month
6month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Investigators

  • Study Director: Keun Soo Bang, LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-ZVOS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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