Clinical trial NCT02415192: Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Leg Edema
Orthostatic Hypertension
Keywords: safety data
hypertension therapy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 2001
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with essential hypertension

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
timeFrame: 6month
Secondary outcomes:
measure: mean change of the blood pressure and pulse after administation of drug at 12week and 24week.
timeFrame: 12weeks, 24weeks
measure: BP control rate
timeFrame: 12weeks, 24weeks
measure: Responder rate
timeFrame: 12weeks, 24weeks
measure: Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available
timeFrame: 12weeks, 24weeks
measure: Evaluation of cardiovascular risk
timeFrame: 12weeks, 24weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: LG Life Science
state: Jongno gu
Study officials:
affiliation: LG Life Sciences
name: Keun Soo Bang
role: STUDY_DIRECTOR
References: