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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)

Primary Purpose

Primary Dyslipidemia, Mixed Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pitavastatin
pravastatin
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dyslipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pitavastatin 4 mg once daily (QD)

pravastatin 40 mg once daily (QD)

Arm Description

Outcomes

Primary Outcome Measures

Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12

Secondary Outcome Measures

Full Information

First Posted
December 7, 2010
Last Updated
May 2, 2012
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01256476
Brief Title
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
Acronym
PREVAIL-US
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dyslipidemia, Mixed Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pitavastatin 4 mg once daily (QD)
Arm Type
Experimental
Arm Title
pravastatin 40 mg once daily (QD)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pitavastatin
Other Intervention Name(s)
Livalo
Intervention Description
pitavastatin 4 mg once daily (QD)
Intervention Type
Drug
Intervention Name(s)
pravastatin
Intervention Description
Pravastatin 40 mg once daily (QD)
Primary Outcome Measure Information:
Title
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Muscle Shoals
State/Province
Alabama
Country
United States
City
Chandler
State/Province
Arizona
Country
United States
City
Goodyear
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Deland
State/Province
Florida
Country
United States
City
Fort Luaderdale
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Ovido
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Ponte Vedra
State/Province
Florida
Country
United States
City
Addison
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Erlanger
State/Province
Kentucky
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Brockton
State/Province
Massachusetts
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Willoughby Hills
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Eugene
State/Province
Oregon
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Olympia
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26922296
Citation
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. Erratum In: Clin Ther. 2017 Mar;39(3):663.
Results Reference
derived
PubMed Identifier
24998014
Citation
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.
Results Reference
derived
PubMed Identifier
24328357
Citation
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.
Results Reference
derived

Learn more about this trial

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

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