Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
Phase 3
Withdrawn
- Conditions
- HyperlipidemiaDyslipidemia
- Interventions
- Registration Number
- NCT02670434
- Lead Sponsor
- Kowa Research Institute, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NK-104-CR NK-104-CR Controlled release NK-104 Placebo Placebo Livalo Placebo Livalo® Immediate Release IR Livalo Immediate Release Livalo®
- Primary Outcome Measures
Name Time Method Percent change in LDL-C from baseline 12 Weeks
- Secondary Outcome Measures
Name Time Method The percent change from baseline in fasting serum total cholesterol (TC ) 12 Weeks