Clinical trial NCT02799758: Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hyperlipidemia
Dyslipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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%

Primary outcomes:
measure: Percent change in Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline to Week 12 endpoint
Secondary outcomes:
Other outcomes:
Locations:
city: Foley
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Greenbrae
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Lomita
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Tustin
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Milford
country: United States
state: Connecticut
city: Atlantis
country: United States
state: Florida
city: Cooper City
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Fleming Island
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Dawsonville
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Suwanee
country: United States
state: Georgia
city: Addison
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Morton
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Topeka
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Oxon Hill
country: United States
state: Maryland
city: Biloxi
country: United States
state: Mississippi
city: Olive Branch
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Manlius
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Jersey Shore
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Moncks Corner
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Suffolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Kenosha
country: United States
state: Wisconsin
Study officials:
References: