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

May 2, 2012 updated by: Kowa Research Institute, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Goodyear, Arizona, United States
      • Phoenix, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Los Angeles, California, United States
      • Newport Beach, California, United States
    • Colorado
      • Colorado Springs, Colorado, 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
    • Illinois
      • Addison, Illinois, United States
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Erlanger, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Brockton, Massachusetts, United States
    • Minnesota
      • Edina, Minnesota, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Statesville, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Willoughby Hills, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
    • South Carolina
      • Greer, South Carolina, United States
      • Mt. Pleasant, South Carolina, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Olympia, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pitavastatin 4 mg once daily (QD)
Drug: pitavastatin
pitavastatin 4 mg once daily (QD)
Other Names:
  • Livalo
ACTIVE_COMPARATOR: pravastatin 40 mg once daily (QD)
Drug: pravastatin
Pravastatin 40 mg once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (ESTIMATE)

December 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-104-4.04US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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