Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
PREVAIL-US
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
1 other identifier
interventional
328
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2010
Shorter than P25 for phase_4
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 7, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
April 30, 2012
CompletedMay 8, 2012
May 1, 2012
8 months
December 7, 2010
April 3, 2012
May 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Baseline and 12 weeks
Study Arms (2)
pitavastatin 4 mg once daily (QD)
EXPERIMENTALpravastatin 40 mg once daily (QD)
ACTIVE COMPARATORInterventions
pitavastatin 4 mg once daily (QD)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Homozygous familial hypercholesterolemia
- Any conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
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Chandler, Arizona, United States
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Goodyear, Arizona, United States
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Phoenix, Arizona, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Colorado Springs, Colorado, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Fort Luaderdale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Oviedo, Florida, United States
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Pembroke Pines, Florida, United States
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Ponte Vedra, Florida, United States
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Addison, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Erlanger, Kentucky, United States
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Baltimore, Maryland, United States
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Brockton, Massachusetts, United States
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Edina, Minnesota, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Rochester, New York, United States
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Statesville, North Carolina, United States
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Cincinnati, Ohio, United States
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Lyndhurst, Ohio, United States
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Willoughby Hills, Ohio, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
Unknown Facility
Olympia, Washington, United States
Related Publications (3)
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.
PMID: 26922296DERIVEDSponseller 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.
PMID: 24998014DERIVEDChapman 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.
PMID: 24328357DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roger Morgan, MD, FACS
- Organization
- Kowa Research Institute, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2010
First Posted
December 8, 2010
Study Start
October 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
May 8, 2012
Results First Posted
April 30, 2012
Record last verified: 2012-05