NCT02670434WithdrawnPhase 3
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Primary Endpoint
- Percent change in LDL-C from baseline
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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%
Arms & Interventions
NK-104-CR
Experimental
Controlled release NK-104
Intervention: NK-104-CR (Drug)
Placebo
Placebo Comparator
Livalo Placebo
Intervention: Placebo (Drug)
Livalo® Immediate Release IR
Active Comparator
Immediate Release Livalo®
Intervention: Livalo (Drug)
Outcomes
Primary Outcomes
Percent change in LDL-C from baseline
Time Frame: 12 Weeks
Secondary Outcomes
- The percent change from baseline in fasting serum total cholesterol (TC )(12 Weeks)
Investigators
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