Dyslipidemia, Hyperlipidemia
Conditions
Brief summary
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
Interventions
DRUGNK-104-CR
NK-104-CR 8 mg daily for 52 weeks
DRUGPlacebo
Placebo daily for 12 weeks
DRUGLivalo
Livalo® IR daily from week 12 to week 52
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 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C from baseline | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| The percent change from baseline in fasting serum total cholesterol (TC ) | 12 Weeks |
Countries
United States
Outcome results
None listed