Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients
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|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
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|
|Study Type :||Observational|
|Estimated Enrollment :||2001 participants|
|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|
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.
Patients treated with Valsartan/amlodipine
In this group, the patients will be enrolled treated with Valsartan/amlodipine combination drug as an anti-hypertensive drug.
- 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 ]
- mean change of the blood pressure and pulse after administation of drug at 12week and 24week. [ Time Frame: 12weeks, 24weeks ]
- BP control rate [ Time Frame: 12weeks, 24weeks ]
- Responder rate [ Time Frame: 12weeks, 24weeks ]
- Evaluation of the changes in metabolic syndrome markers after treatment if the factors are available [ Time Frame: 12weeks, 24weeks ]
- Evaluation of cardiovascular risk [ Time Frame: 12weeks, 24weeks ]
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
|Contact: Hye Jin Yoonfirstname.lastname@example.org|
|Korea, Republic of|
|LG Life Science||Recruiting|
|Seoul, Jongno gu, Korea, Republic of, 110-783|
|Contact: Hye jin Yoon|
|Study Director:||Keun Soo Bang||LG Life Science|