Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-24 @ 9:23 PM
Study NCT ID:
NCT02415192
Status:
UNKNOWN
Last Update Posted:
2016-04-19
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients
Sponsor:
LG Life Sciences
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: