Dyslipidemia, Hyperlipidemia
Conditions
Brief summary
The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment
Interventions
DRUGNK-104-CR
NK-104-CR 8 mg for 52 weeks
DRUGLivalo® IR
Livalo® IR 4 mg daily for 52 weeks
DRUGPlacebo (for NK-104-CR)
NK-104-CR 8 mg placebo for 52 weeks
DRUGPlacebo (for Livalo® IR)
Livalo® IR 4 mg placebo for 52 weeks
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with primary hyperlipidemia or mixed dyslipidemia * Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII * Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 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 \>9%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Low-density lipoprotein cholesterol (LDL-C) | Baseline to Week 12 endpoint |
Countries
United States
Outcome results
None listed