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Trial record 26 of 99 for:    AMLODIPINE AND VALSARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02415192
Recruitment Status : Unknown
Verified April 2016 by LG Life Sciences.
Recruitment status was:  Recruiting
First Posted : April 14, 2015
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Lower Leg Edema Orthostatic Hypertension Drug: Levacalm Drug: Valsartan/amlodipine

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Study Type : Observational
Estimated Enrollment : 2001 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : July 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. mean change of the blood pressure and pulse after administation of drug at 12week and 24week. [ Time Frame: 12weeks, 24weeks ]
  2. BP control rate [ Time Frame: 12weeks, 24weeks ]
  3. Responder rate [ Time Frame: 12weeks, 24weeks ]
  4. Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available [ Time Frame: 12weeks, 24weeks ]
  5. Evaluation of cardiovascular risk [ Time Frame: 12weeks, 24weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with essential hypertension
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415192


Contacts
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Contact: Hye Jin Yoon 82-2-6924-3148 hyejin0611@lgls.com

Locations
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Korea, Republic of
LG Life Science Recruiting
Seoul, Jongno gu, Korea, Republic of, 110-783
Contact: Hye jin Yoon         
Sponsors and Collaborators
LG Life Sciences
Investigators
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Study Director: Keun Soo Bang LG Life Science

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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02415192     History of Changes
Other Study ID Numbers: LG-ZVOS001
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by LG Life Sciences:
safety data
hypertension therapy
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists