NCT02415192

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,001 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Leg Edema
• Orthostatic Hypertension

Interventions

Type	Name	Description
DRUG	Levacalm
DRUG	Valsartan/amlodipine

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2015-04-14
• Last updated: 2016-04-19

Locations

1 site across 1 country: South Korea