NCT02415192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

April 8, 2015

Last Update Submit

April 18, 2016

Conditions

Lower Leg EdemaOrthostatic Hypertension

Keywords

safety datahypertension therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    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

Study Arms (2)

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

Interventions

LevacalmDRUG
Patients treated with Levacalm
Valsartan/amlodipineDRUG
Patients treated with Valsartan/amlodipine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with essential hypertension

You may qualify if:

  • patients aged over 19 with essential hypertension
  • those who can't maintain the blood pressure with the antihypertensive drug before.
  • those who diagnosed to a hypertension stage 2.(DBP is higher than 160mmHg or SBP is higher than 100mmHg)
  • 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.

You may not qualify if:

  • Those who are included in the contraindication of study drug following the information for use of the product
  • Those who is/will be participated in other drug clinical trial
  • Those who adminitrated other antihypertensive drugs beside the levacalm or Valsartan/amlodipine combination drug.
  • Those who judged by the invesigator as ineligible for this clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LG Life Science

Seoul, Jongno gu, 110-783, South Korea

RECRUITING

MeSH Terms

Interventions

Amlodipine, Valsartan Drug Combination

Intervention Hierarchy (Ancestors)

ValsartanTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmlodipineDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical Preparations

Study Officials

  • Keun Soo Bang

    LG Life Sciences

    STUDY DIRECTOR

Central Study Contacts

Hye Jin Yoon

CONTACT

82-2-6924-3148hyejin0611@lgls.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 14, 2015

Study Start

July 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

KR(1)