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

NCT02670434 | Withdrawn Phase 3

• 1 other identifier: NK-104-CR-3.01US
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 45

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

Conditions

Hyperlipidemia; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C from baseline

  12 Weeks

Secondary Outcomes (1)

• The percent change from baseline in fasting serum total cholesterol (TC )

  12 Weeks

Study Arms (3)

NK-104-CR

EXPERIMENTAL

Controlled release NK-104

Drug: NK-104-CR

Placebo

PLACEBO COMPARATOR

Livalo Placebo

Drug: Placebo

Livalo® Immediate Release IR

ACTIVE COMPARATOR

Immediate Release Livalo®

Drug: Livalo

Interventions

NK-104-CR DRUG

NK-104-CR 8 mg daily for 52 weeks

NK-104-CR

Placebo DRUG

Placebo daily for 12 weeks

Placebo

Livalo DRUG

Livalo® IR daily from week 12 to week 52

Livalo® Immediate Release IR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Homozygous familial hypercholesterolemia;
• Any conditions which may cause secondary dyslipidemia.
• Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c \>8%

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (45)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Chino, California, United States

Location

Unknown Facility

Lincoln, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

North Hollywood, California, United States

Location

Unknown Facility

Thousand Oaks, California, United States

Location

Unknown Facility

Vista, California, United States

Location

Unknown Facility

Brooksville, Florida, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Jupiter, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Port Orange, Florida, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Meridian, Idaho, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Newton, Kansas, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Auburn, Maine, United States

Location

Unknown Facility

Elkridge, Maryland, United States

Location

Unknown Facility

Edina, Minnesota, United States

Location

Unknown Facility

Jackson, Mississippi, United States

Location

Unknown Facility

Butte, Montana, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Berlin, New Jersey, United States

Location

Unknown Facility

Endwell, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Kettering, Ohio, United States

Location

Unknown Facility

Lyndhurst, Ohio, United States

Location

Unknown Facility

Marion, Ohio, United States

Location

Unknown Facility

Willoughby Hills, Ohio, United States

Location

Unknown Facility

Downingtown, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, United States

Location

Unknown Facility

Kingsport, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Hurst, Texas, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Dyslipidemias

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (45)