Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
NCT ID: NCT01256476
Last Updated: 2012-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
328 participants
INTERVENTIONAL
2010-10-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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pitavastatin 4 mg once daily (QD)
pitavastatin
pitavastatin 4 mg once daily (QD)
pravastatin 40 mg once daily (QD)
pravastatin
Pravastatin 40 mg once daily (QD)
Interventions
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pitavastatin
pitavastatin 4 mg once daily (QD)
pravastatin
Pravastatin 40 mg once daily (QD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Any conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus
18 Years
80 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Goodyear, Arizona, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Colorado Springs, Colorado, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Fort Luaderdale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Ponte Vedra, Florida, United States
Addison, Illinois, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Erlanger, Kentucky, United States
Baltimore, Maryland, United States
Brockton, Massachusetts, United States
Edina, Minnesota, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Rochester, New York, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Lyndhurst, Ohio, United States
Willoughby Hills, Ohio, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Olympia, Washington, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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NK-104-4.04US
Identifier Type: -
Identifier Source: org_study_id
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