Clinical trial NCT02670434: Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients 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Overall status: WITHDRAWN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: 2016-02-01
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 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


Eligibility criteria: 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%

Primary outcomes:
measure: Percent change in LDL-C from baseline
timeFrame: 12 Weeks
Secondary outcomes:
measure: The percent change from baseline in fasting serum total cholesterol (TC )
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Chino
country: United States
state: California
city: Lincoln
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: North Hollywood
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Vista
country: United States
state: California
city: Brooksville
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Auburn
country: United States
state: Maine
city: Elkridge
country: United States
state: Maryland
city: Edina
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Endwell
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Downingtown
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Hurst
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
Study officials:
References: