Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia



Status:Recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:January 2016
End Date:October 2017
Contact:Richard Oh, M.D.
Email:Clinical@KowaUS.com
Phone:919-433-1600

Use our guide to learn which trials are right for you!

The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo®
on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary
hyperlipidemia or mixed dyslipidemia


Inclusion Criteria:

- Male and female patients with primary hyperlipidemia or mixed dyslipidemia who are
≥18 and ≤80 years of age at the time of consent;

- Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL

- Patients who are naïve to statin or who are able to safely discontinue the use of all
lipid-lowering agents for 6 weeks before randomization and throughout study
participation

Exclusion Criteria:

- Homozygous familial hypercholesterolemia;

- Any conditions which may cause secondary dyslipidemia.

- Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >8%
We found this trial at
45
sites
?
mi
from
Newton, KS
Click here to add this to my saved trials
?
mi
from
Auburn, ME
Click here to add this to my saved trials
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Butte, MT
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chino, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Dowingtown, PA
Click here to add this to my saved trials
?
mi
from
Edina, MN
Click here to add this to my saved trials
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
?
mi
from
Endwell, NY
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Ft. Lauderdale, FL
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hurst, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
Kettering, OH
Click here to add this to my saved trials
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lincoln, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Lyndhurst, OH
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Marion, OH
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Thousand Oaks, California 91360
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
?
mi
from
Vista, CA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Willoughby Hills, OH
Click here to add this to my saved trials