Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

Kowa

Status and phase: Withdrawn; Phase 3

Conditions: Hyperlipidemia; Dyslipidemia

Treatments: Drug: Livalo® IR; Drug: Placebo (for Livalo® IR); Drug: NK-104-CR; Drug: Placebo (for NK-104-CR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02799758

NK-104-CR-3.02US

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

NK-104-CR

Experimental group

Description:

NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.

Treatment:

Drug: Placebo (for Livalo® IR)

Drug: NK-104-CR

Livalo® IR

Active Comparator group

Description:

Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.

Treatment:

Drug: Livalo® IR

Drug: Placebo (for NK-104-CR)