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

Kowa

Status and phase: Withdrawn; Phase 3

Conditions: Hyperlipidemia; Dyslipidemia

Treatments: Drug: Livalo; Drug: NK-104-CR; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02670434

NK-104-CR-3.01US

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

NK-104-CR

Experimental group

Description:

Controlled release NK-104

Treatment:

Drug: NK-104-CR

Placebo

Placebo Comparator group

Description:

Livalo Placebo

Treatment:

Drug: Placebo

Livalo® Immediate Release IR

Active Comparator group

Description:

Immediate Release Livalo®

Treatment:

Drug: Livalo