Clinical trial NCT01256476: Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
Official title: A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Dyslipidemia
Mixed Dyslipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 328
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: Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
* Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Any conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus

Primary outcomes:
measure: Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Goodyear
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Fort Luaderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ovido
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Ponte Vedra
country: United States
state: Florida
city: Addison
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Erlanger
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Greer
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
Study officials:
References:
citation: Miller PE, Martin SS, Joshi PH, Jones SR, Massaro JM, D'Agostino RB, Sponseller CA, Toth PP. Pitavastatin 4 mg Provides Significantly Greater Reduction in Remnant Lipoprotein Cholesterol Compared With Pravastatin 40 mg: Results from the Short-term Phase IV PREVAIL US Trial in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia. Clin Ther. 2016 Mar;38(3):603-9. doi: 10.1016/j.clinthera.2016.02.001. Epub 2016 Feb 26.
citation: Sponseller CA, Morgan RE, Kryzhanovski VA, Campbell SE, Davidson MH. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clin Ther. 2014 Aug 1;36(8):1211-22. doi: 10.1016/j.clinthera.2014.06.009. Epub 2014 Jul 3.
citation: Chapman MJ, Orsoni A, Robillard P, Hounslow N, Sponseller CA, Giral P. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014 May;30(5):775-84. doi: 10.1185/03007995.2013.874989. Epub 2014 Jan 10.