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

Orthostatic Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415192
• Other study ID #: LG-ZVOS001
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2015
• Last updated: April 18, 2016
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: LG Life Sciences
• Contact: Hye Jin Yoon
• Phone: 82-2-6924-3148
• Email: hyejin0611[@]lgls.com
• Is FDA regulated: No
• Health authority: South Korea : Korea Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2001
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Lower Leg Edema
• Orthostatic Hypertension

Intervention

Drug:
• Levacalm

• Valsartan/amlodipine

Locations

Country	Name	City	State
Korea, Republic of	LG Life Science	Seoul	Jongno gu

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.		6month	Yes
Secondary	mean change of the blood pressure and pulse after administation of drug at 12week and 24week.		12weeks, 24weeks	No
Secondary	BP control rate		12weeks, 24weeks	No
Secondary	Responder rate		12weeks, 24weeks	No
Secondary	Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available		12weeks, 24weeks	No
Secondary	Evaluation of cardiovascular risk		12weeks, 24weeks	No