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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01256476
First received: December 7, 2010
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Primary Dyslipidemia
Mixed Dyslipidemia
 Drug: pitavastatin
Drug: pravastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 328
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256476

  Hide Study Locations
Locations
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.
  More Information

No publications provided

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01256476     History of Changes
Other Study ID Numbers: NK-104-4.04US
Study First Received: December 7, 2010
Results First Received: April 3, 2012
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013