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Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia (PREVAIL-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01256476
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : April 30, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
Primary Dyslipidemia Mixed Dyslipidemia Drug: pitavastatin Drug: pravastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pitavastatin 4 mg once daily (QD) Drug: pitavastatin
pitavastatin 4 mg once daily (QD)
Other Name: Livalo

Active Comparator: pravastatin 40 mg once daily (QD) Drug: pravastatin
Pravastatin 40 mg once daily (QD)




Primary Outcome Measures :
  1. Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256476


Locations
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United States, Alabama
Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
United States, Arizona
Chandler, Arizona, United States
Goodyear, Arizona, United States
Phoenix, Arizona, United States
United States, California
Beverly Hills, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Florida
Clearwater, Florida, United States
Deland, Florida, United States
Fort Luaderdale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Ovido, Florida, United States
Pembroke Pines, Florida, United States
Ponte Vedra, Florida, United States
United States, Illinois
Addison, Illinois, United States
Chicago, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Erlanger, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Brockton, Massachusetts, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Berlin, New Jersey, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Statesville, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Lyndhurst, Ohio, United States
Willoughby Hills, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
United States, South Carolina
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
United States, Texas
Corpus Christi, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Olympia, Washington, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01256476    
Other Study ID Numbers: NK-104-4.04US
First Posted: December 8, 2010    Key Record Dates
Results First Posted: April 30, 2012
Last Update Posted: May 8, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors